Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K; 7) DEPAUL DAVINCI CDS, REF CDS982377K; 8) GU DAVINCI, REF CDS982779N; 9) GYN DAVINCI, REF CDS982780V; 10) UNIVERSAL ROBOTIC ORLANDO, REF CDS982857K; 11) ROBOTIC GU/GYN, REF CDS983393L; 12) GYN LAPAROSCOPY CDS, REF CDS984656Q; 13) GYN LAPAROSCOPY CDS, REF CDS984656R; 14) DAVINCI CDS UCC-LF, REF CDS984663J; 15) ROBOTIC UROLOGY PROSTATE, REF CDS985467J; 16) DAVINCI PROSTATECTOMY, REF DYNJG901002B; 17) ROBOTIC PACK IMF 100913- LF, REF DYNJVB91075C; 18) ROBOTIC PACK, REF DYNJ36840L; 19) ROBOTIC PACK MNMC, REF DYNJ38152D; 20) WMC GYN LAPAROSCOPY PACK-LF, REF DYNJ50649J; 21) ROBOTIC GASTRIC BYPASS PACK, REF DYNJ52096P; 22) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564D; 23) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564F; 24) GYN ROBOTIC PACK, REF DYNJ52581D; 25) GYN LAPAROSCOPY PACK, REF DYNJ53782J; 26) UNIVERSAL DAVINCI ROBOTIC P, REF DYNJ53968P; 27) WALKER GYN-UROLOGY ROBOTIC PK, REF DYNJ57458B; 28) GYN LAPAROSCOPY, REF DYNJ62136B; 29) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392F; 30) TOTAL LAPAROSCOPIC HYST PACK, REF DYNJ63456B; 31) ROBOTIC PACK, REF DYNJ67177D; 32) MH GYN LAPAROSCOPY PACK-LF, REF DYNJ84433B; 33) DAVINCI, REF DYNJ900963M; 34) LEX DAVINCI GYN MAJOR, REF DYNJ900965N; 35) LEX DAVINCI UROLOGY, REF DYNJ900967N; 36) COR DAVINCI, REF DYNJ901018O; 37) GYN ROBOTIC, REF DYNJ901046M; 38) DAVINCI, REF DYNJ901076L; 39) GYN ROBOTIC, REF DYNJ901796K; 40) LOU GENERAL ROBOT, REF DYNJ901844N; 41) LOU GYN LAPAROSCOPY, REF DYNJ901845L; 42) LOU GYN LAPAROSCOPY, REF DYNJ901845M; 43) LOU LITHOTOMY ROBOTIC, REF DYNJ901850N; 44) LEX GYN MINOR LAPAROSCOPY, REF DYNJ902029G; 45) GYN ROBOT, REF DYNJ902513J; 46) CHN OR DAVINCI PROSTATE, REF DYNJ902540O; 47) WMC ROBOTIC PACK - LF, REF DYNJ902583N; 48) ROBOTIC GYN & GU, REF DYNJ903459J; 49) GYN LAPAROSCOPY-LF, REF DYNJ903647I; 50) ROBOTIC UROLOGY, REF DYNJ903827F; 51) LITHOTOMY ROBOTIC CDS, REF DYNJ903948R; 52) GYN ROBOTIC, REF DYNJ903983P; 53) GYN LAP, REF DYNJ903990Q; 54) ROBOTIC-LF, REF DYNJ904254L; 55) ROBOTIC, REF DYNJ904343G; 56) ROBOT GYN, REF DYNJ904572L; 57) ROBOTIC PROSTECTOMY, REF DYNJ904597G; 58) GYN LAPAROSCOPY-LF, REF DYNJ905289G; 59) GYN ROBOTIC, REF DYNJ905730J; 60) URO ROBOTIC, REF DYNJ905746J; 61) COLON KIT, REF DYNJ905964G; 62) CHN OR ROBOTIC GYN, REF DYNJ905985O; 63) CW ROBOT, REF DYNJ906051C; 64) CW ROBOT, REF DYNJ906051D; 65) ROBOT, REF DYNJ906112B; 66) CDS ROBOTIC GYN CH, REF DYNJ906265D; 67) ROBOTIC GYN PACK, REF DYNJ906265F; 68) KIT GYN LAPAROSCOPY RFD, REF DYNJ906322F; 69) GYN LAPAROSCOPY, REF DYNJ906357C; 70) ROBOTIC COLON, REF DYNJ906379D; 71) GYN DAVINCI FOAKS, REF DYNJ906444C; 72) DAVINCI, REF DYNJ906543B; 73) CHN GYN ONCOLOGY, REF DYNJ906731K; 74) CHN ROBOTIC CYSTECTOMY, REF DYNJ907072F; 75) WMC THORACIC ROBOTIC, REF DYNJ907153C; 76) WMC THORACIC ROBOTIC, REF DYNJ907153D; 77) GYN ROBOTIC, REF DYNJ907492F; 78) KIT LAP GYN NTX, REF DYNJ907599C; 79) KIT ROBOTIC GYN, REF DYNJ907635D; 80) KIT ROBOTIC GYN, REF DYNJ907647B; 81) ROBOTIC-LF, REF DYNJ907910F; 82) ROBOTIC GENERAL, REF DYNJ907919C; 83) ROBOTIC BASE, REF DYNJ908447D; 84) ROBOTIC BASE, REF DYNJ908447F; 85) GYN, REF DYNJ908504A; 86) GU DAVINCI KIT, REF DYNJ908783F; 87) ROBOTIC PROSTATE, REF DYNJ909120D; 88) OSC ROBOT BARIATRIC, REF DYNJ909547; 89) LEX DAVINCI PROSTATE, REF DYNJ909548A; 90) GYN-URO ROBOT, REF DYNJ910137A; 91) PROSTATECTOMY ROBOTIC, REF DYNJ910991; 92) GYN ROBOTIC, REF DYNJ910995; 93) ROBOTIC, REF DYNJ9225761X; 94) DAVINCI ROBOTIC PACK-LF, REF DYNJ9288198X; 95) MB GYN ROBOTIC ADD, REF DYNJ9701096M; 96) PHS722500FCK, REF PHS722500G.
USMedline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K; 7) DEPAUL DAVINCI CDS, REF CDS982377K; 8) GU DAVINCI, REF CDS982779N; 9) GYN DAVINCI, REF CDS982780V; 10) UNIVERSAL ROBOTIC ORLANDO, REF CDS982857K; 11) ROBOTIC GU/GYN, REF CDS983393L; 12) GYN LAPAROSCOPY CDS, REF CDS984656Q; 13) GYN LAPAROSCOPY CDS, REF CDS984656R; 14) DAVINCI CDS UCC-LF, REF CDS984663J; 15) ROBOTIC UROLOGY PROSTATE, REF CDS985467J; 16) DAVINCI PROSTATECTOMY, REF DYNJG901002B; 17) ROBOTIC PACK IMF 100913- LF, REF DYNJVB91075C; 18) ROBOTIC PACK, REF DYNJ36840L; 19) ROBOTIC PACK MNMC, REF DYNJ38152D; 20) WMC GYN LAPAROSCOPY PACK-LF, REF DYNJ50649J; 21) ROBOTIC GASTRIC BYPASS PACK, REF DYNJ52096P; 22) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564D; 23) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564F; 24) GYN ROBOTIC PACK, REF DYNJ52581D; 25) GYN LAPAROSCOPY PACK, REF DYNJ53782J; 26) UNIVERSAL DAVINCI ROBOTIC P, REF DYNJ53968P; 27) WALKER GYN-UROLOGY ROBOTIC PK, REF DYNJ57458B; 28) GYN LAPAROSCOPY, REF DYNJ62136B; 29) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392F; 30) TOTAL LAPAROSCOPIC HYST PACK, REF DYNJ63456B; 31) ROBOTIC PACK, REF DYNJ67177D; 32) MH GYN LAPAROSCOPY PACK-LF, REF DYNJ84433B; 33) DAVINCI, REF DYNJ900963M; 34) LEX DAVINCI GYN MAJOR, REF DYNJ900965N; 35) LEX DAVINCI UROLOGY, REF DYNJ900967N; 36) COR DAVINCI, REF DYNJ901018O; 37) GYN ROBOTIC, REF DYNJ901046M; 38) DAVINCI, REF DYNJ901076L; 39) GYN ROBOTIC, REF DYNJ901796K; 40) LOU GENERAL ROBOT, REF DYNJ901844N; 41) LOU GYN LAPAROSCOPY, REF DYNJ901845L; 42) LOU GYN LAPAROSCOPY, REF DYNJ901845M; 43) LOU LITHOTOMY ROBOTIC, REF DYNJ901850N; 44) LEX GYN MINOR LAPAROSCOPY, REF DYNJ902029G; 45) GYN ROBOT, REF DYNJ902513J; 46) CHN OR DAVINCI PROSTATE, REF DYNJ902540O; 47) WMC ROBOTIC PACK - LF, REF DYNJ902583N; 48) ROBOTIC GYN & GU, REF DYNJ903459J; 49) GYN LAPAROSCOPY-LF, REF DYNJ903647I; 50) ROBOTIC UROLOGY, REF DYNJ903827F; 51) LITHOTOMY ROBOTIC CDS, REF DYNJ903948R; 52) GYN ROBOTIC, REF DYNJ903983P; 53) GYN LAP, REF DYNJ903990Q; 54) ROBOTIC-LF, REF DYNJ904254L; 55) ROBOTIC, REF DYNJ904343G; 56) ROBOT GYN, REF DYNJ904572L; 57) ROBOTIC PROSTECTOMY, REF DYNJ904597G; 58) GYN LAPAROSCOPY-LF, REF DYNJ905289G; 59) GYN ROBOTIC, REF DYNJ905730J; 60) URO ROBOTIC, REF DYNJ905746J; 61) COLON KIT, REF DYNJ905964G; 62) CHN OR ROBOTIC GYN, REF DYNJ905985O; 63) CW ROBOT, REF DYNJ906051C; 64) CW ROBOT, REF DYNJ906051D; 65) ROBOT, REF DYNJ906112B; 66) CDS ROBOTIC GYN CH, REF DYNJ906265D; 67) ROBOTIC GYN PACK, REF DYNJ906265F; 68) KIT GYN LAPAROSCOPY RFD, REF DYNJ906322F; 69) GYN LAPAROSCOPY, REF DYNJ906357C; 70) ROBOTIC COLON, REF DYNJ906379D; 71) GYN DAVINCI FOAKS, REF DYNJ906444C; 72) DAVINCI, REF DYNJ906543B; 73) CHN GYN ONCOLOGY, REF DYNJ906731K; 74) CHN ROBOTIC CYSTECTOMY, REF DYNJ907072F; 75) WMC THORACIC ROBOTIC, REF DYNJ907153C; 76) WMC THORACIC ROBOTIC, REF DYNJ907153D; 77) GYN ROBOTIC, REF DYNJ907492F; 78) KIT LAP GYN NTX, REF DYNJ907599C; 79) KIT ROBOTIC GYN, REF DYNJ907635D; 80) KIT ROBOTIC GYN, REF DYNJ907647B; 81) ROBOTIC-LF, REF DYNJ907910F; 82) ROBOTIC GENERAL, REF DYNJ907919C; 83) ROBOTIC BASE, REF DYNJ908447D; 84) ROBOTIC BASE, REF DYNJ908447F; 85) GYN, REF DYNJ908504A; 86) GU DAVINCI KIT, REF DYNJ908783F; 87) ROBOTIC PROSTATE, REF DYNJ909120D; 88) OSC ROBOT BARIATRIC, REF DYNJ909547; 89) LEX DAVINCI PROSTATE, REF DYNJ909548A; 90) GYN-URO ROBOT, REF DYNJ910137A; 91) PROSTATECTOMY ROBOTIC, REF DYNJ910991; 92) GYN ROBOTIC, REF DYNJ910995; 93) ROBOTIC, REF DYNJ9225761X; 94) DAVINCI ROBOTIC PACK-LF, REF DYNJ9288198X; 95) MB GYN ROBOTIC ADD, REF DYNJ9701096M; 96) PHS722500FCK, REF PHS722500G.
Recalling Firm: Medline Industries, LP
Motivo del Retiro / Peligro
TranslatedMedline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Descripción del Producto e Identificación
TranslatedMedline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K; 7) DEPAUL DAVINCI CDS, REF CDS982377K; 8) GU DAVINCI, REF CDS982779N; 9) GYN DAVINCI, REF CDS982780V; 10) UNIVERSAL ROBOTIC ORLANDO, REF CDS982857K; 11) ROBOTIC GU/GYN, REF CDS983393L; 12) GYN LAPAROSCOPY CDS, REF CDS984656Q; 13) GYN LAPAROSCOPY CDS, REF CDS984656R; 14) DAVINCI CDS UCC-LF, REF CDS984663J; 15) ROBOTIC UROLOGY PROSTATE, REF CDS985467J; 16) DAVINCI PROSTATECTOMY, REF DYNJG901002B; 17) ROBOTIC PACK IMF 100913- LF, REF DYNJVB91075C; 18) ROBOTIC PACK, REF DYNJ36840L; 19) ROBOTIC PACK MNMC, REF DYNJ38152D; 20) WMC GYN LAPAROSCOPY PACK-LF, REF DYNJ50649J; 21) ROBOTIC GASTRIC BYPASS PACK, REF DYNJ52096P; 22) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564D; 23) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564F; 24) GYN ROBOTIC PACK, REF DYNJ52581D; 25) GYN LAPAROSCOPY PACK, REF DYNJ53782J; 26) UNIVERSAL DAVINCI ROBOTIC P, REF DYNJ53968P; 27) WALKER GYN-UROLOGY ROBOTIC PK, REF DYNJ57458B; 28) GYN LAPAROSCOPY, REF DYNJ62136B; 29) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392F; 30) TOTAL LAPAROSCOPIC HYST PACK, REF DYNJ63456B; 31) ROBOTIC PACK, REF DYNJ67177D; 32) MH GYN LAPAROSCOPY PACK-LF, REF DYNJ84433B; 33) DAVINCI, REF DYNJ900963M; 34) LEX DAVINCI GYN MAJOR, REF DYNJ900965N; 35) LEX DAVINCI UROLOGY, REF DYNJ900967N; 36) COR DAVINCI, REF DYNJ901018O; 37) GYN ROBOTIC, REF DYNJ901046M; 38) DAVINCI, REF DYNJ901076L; 39) GYN ROBOTIC, REF DYNJ901796K; 40) LOU GENERAL ROBOT, REF DYNJ901844N; 41) LOU GYN LAPAROSCOPY, REF DYNJ901845L; 42) LOU GYN LAPAROSCOPY, REF DYNJ901845M; 43) LOU LITHOTOMY ROBOTIC, REF DYNJ901850N; 44) LEX GYN MINOR LAPAROSCOPY, REF DYNJ902029G; 45) GYN ROBOT, REF DYNJ902513J; 46) CHN OR DAVINCI PROSTATE, REF DYNJ902540O; 47) WMC ROBOTIC PACK - LF, REF DYNJ902583N; 48) ROBOTIC GYN & GU, REF DYNJ903459J; 49) GYN LAPAROSCOPY-LF, REF DYNJ903647I; 50) ROBOTIC UROLOGY, REF DYNJ903827F; 51) LITHOTOMY ROBOTIC CDS, REF DYNJ903948R; 52) GYN ROBOTIC, REF DYNJ903983P; 53) GYN LAP, REF DYNJ903990Q; 54) ROBOTIC-LF, REF DYNJ904254L; 55) ROBOTIC, REF DYNJ904343G; 56) ROBOT GYN, REF DYNJ904572L; 57) ROBOTIC PROSTECTOMY, REF DYNJ904597G; 58) GYN LAPAROSCOPY-LF, REF DYNJ905289G; 59) GYN ROBOTIC, REF DYNJ905730J; 60) URO ROBOTIC, REF DYNJ905746J; 61) COLON KIT, REF DYNJ905964G; 62) CHN OR ROBOTIC GYN, REF DYNJ905985O; 63) CW ROBOT, REF DYNJ906051C; 64) CW ROBOT, REF DYNJ906051D; 65) ROBOT, REF DYNJ906112B; 66) CDS ROBOTIC GYN CH, REF DYNJ906265D; 67) ROBOTIC GYN PACK, REF DYNJ906265F; 68) KIT GYN LAPAROSCOPY RFD, REF DYNJ906322F; 69) GYN LAPAROSCOPY, REF DYNJ906357C; 70) ROBOTIC COLON, REF DYNJ906379D; 71) GYN DAVINCI FOAKS, REF DYNJ906444C; 72) DAVINCI, REF DYNJ906543B; 73) CHN GYN ONCOLOGY, REF DYNJ906731K; 74) CHN ROBOTIC CYSTECTOMY, REF DYNJ907072F; 75) WMC THORACIC ROBOTIC, REF DYNJ907153C; 76) WMC THORACIC ROBOTIC, REF DYNJ907153D; 77) GYN ROBOTIC, REF DYNJ907492F; 78) KIT LAP GYN NTX, REF DYNJ907599C; 79) KIT ROBOTIC GYN, REF DYNJ907635D; 80) KIT ROBOTIC GYN, REF DYNJ907647B; 81) ROBOTIC-LF, REF DYNJ907910F; 82) ROBOTIC GENERAL, REF DYNJ907919C; 83) ROBOTIC BASE, REF DYNJ908447D; 84) ROBOTIC BASE, REF DYNJ908447F; 85) GYN, REF DYNJ908504A; 86) GU DAVINCI KIT, REF DYNJ908783F; 87) ROBOTIC PROSTATE, REF DYNJ909120D; 88) OSC ROBOT BARIATRIC, REF DYNJ909547; 89) LEX DAVINCI PROSTATE, REF DYNJ909548A; 90) GYN-URO ROBOT, REF DYNJ910137A; 91) PROSTATECTOMY ROBOTIC, REF DYNJ910991; 92) GYN ROBOTIC, REF DYNJ910995; 93) ROBOTIC, REF DYNJ9225761X; 94) DAVINCI ROBOTIC PACK-LF, REF DYNJ9288198X; 95) MB GYN ROBOTIC ADD, REF DYNJ9701096M; 96) PHS722500FCK, REF PHS722500G.
Productos Afectados
TranslatedMedline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K; 7) DEPAUL DAVINCI CDS, REF CDS982377K; 8) GU DAVINCI, REF CDS982779N; 9) GYN DAVINCI, REF CDS982780V; 10) UNIVERSAL ROBOTIC ORLANDO, REF CDS982857K; 11) ROBOTIC GU/GYN, REF CDS983393L; 12) GYN LAPAROSCOPY CDS, REF CDS984656Q; 13) GYN LAPAROSCOPY CDS, REF CDS984656R; 14) DAVINCI CDS UCC-LF, REF CDS984663J; 15) ROBOTIC UROLOGY PROSTATE, REF CDS985467J; 16) DAVINCI PROSTATECTOMY, REF DYNJG901002B; 17) ROBOTIC PACK IMF 100913- LF, REF DYNJVB91075C; 18) ROBOTIC PACK, REF DYNJ36840L; 19) ROBOTIC PACK MNMC, REF DYNJ38152D; 20) WMC GYN LAPAROSCOPY PACK-LF, REF DYNJ50649J; 21) ROBOTIC GASTRIC BYPASS PACK, REF DYNJ52096P; 22) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564D; 23) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564F; 24) GYN ROBOTIC PACK, REF DYNJ52581D; 25) GYN LAPAROSCOPY PACK, REF DYNJ53782J; 26) UNIVERSAL DAVINCI ROBOTIC P, REF DYNJ53968P; 27) WALKER GYN-UROLOGY ROBOTIC PK, REF DYNJ57458B; 28) GYN LAPAROSCOPY, REF DYNJ62136B; 29) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392F; 30) TOTAL LAPAROSCOPIC HYST PACK, REF DYNJ63456B; 31) ROBOTIC PACK, REF DYNJ67177D; 32) MH GYN LAPAROSCOPY PACK-LF, REF DYNJ84433B; 33) DAVINCI, REF DYNJ900963M; 34) LEX DAVINCI GYN MAJOR, REF DYNJ900965N; 35) LEX DAVINCI UROLOGY, REF DYNJ900967N; 36) COR DAVINCI, REF DYNJ901018O; 37) GYN ROBOTIC, REF DYNJ901046M; 38) DAVINCI, REF DYNJ901076L; 39) GYN ROBOTIC, REF DYNJ901796K; 40) LOU GENERAL ROBOT, REF DYNJ901844N; 41) LOU GYN LAPAROSCOPY, REF DYNJ901845L; 42) LOU GYN LAPAROSCOPY, REF DYNJ901845M; 43) LOU LITHOTOMY ROBOTIC, REF DYNJ901850N; 44) LEX GYN MINOR LAPAROSCOPY, REF DYNJ902029G; 45) GYN ROBOT, REF DYNJ902513J; 46) CHN OR DAVINCI PROSTATE, REF DYNJ902540O; 47) WMC ROBOTIC PACK - LF, REF DYNJ902583N; 48) ROBOTIC GYN & GU, REF DYNJ903459J; 49) GYN LAPAROSCOPY-LF, REF DYNJ903647I; 50) ROBOTIC UROLOGY, REF DYNJ903827F; 51) LITHOTOMY ROBOTIC CDS, REF DYNJ903948R; 52) GYN ROBOTIC, REF DYNJ903983P; 53) GYN LAP, REF DYNJ903990Q; 54) ROBOTIC-LF, REF DYNJ904254L; 55) ROBOTIC, REF DYNJ904343G; 56) ROBOT GYN, REF DYNJ904572L; 57) ROBOTIC PROSTECTOMY, REF DYNJ904597G; 58) GYN LAPAROSCOPY-LF, REF DYNJ905289G; 59) GYN ROBOTIC, REF DYNJ905730J; 60) URO ROBOTIC, REF DYNJ905746J; 61) COLON KIT, REF DYNJ905964G; 62) CHN OR ROBOTIC GYN, REF DYNJ905985O; 63) CW ROBOT, REF DYNJ906051C; 64) CW ROBOT, REF DYNJ906051D; 65) ROBOT, REF DYNJ906112B; 66) CDS ROBOTIC GYN CH, REF DYNJ906265D; 67) ROBOTIC GYN PACK, REF DYNJ906265F; 68) KIT GYN LAPAROSCOPY RFD, REF DYNJ906322F; 69) GYN LAPAROSCOPY, REF DYNJ906357C; 70) ROBOTIC COLON, REF DYNJ906379D; 71) GYN DAVINCI FOAKS, REF DYNJ906444C; 72) DAVINCI, REF DYNJ906543B; 73) CHN GYN ONCOLOGY, REF DYNJ906731K; 74) CHN ROBOTIC CYSTECTOMY, REF DYNJ907072F; 75) WMC THORACIC ROBOTIC, REF DYNJ907153C; 76) WMC THORACIC ROBOTIC, REF DYNJ907153D; 77) GYN ROBOTIC, REF DYNJ907492F; 78) KIT LAP GYN NTX, REF DYNJ907599C; 79) KIT ROBOTIC GYN, REF DYNJ907635D; 80) KIT ROBOTIC GYN, REF DYNJ907647B; 81) ROBOTIC-LF, REF DYNJ907910F; 82) ROBOTIC GENERAL, REF DYNJ907919C; 83) ROBOTIC BASE, REF DYNJ908447D; 84) ROBOTIC BASE, REF DYNJ908447F; 85) GYN, REF DYNJ908504A; 86) GU DAVINCI KIT, REF DYNJ908783F; 87) ROBOTIC PROSTATE, REF DYNJ909120D; 88) OSC ROBOT BARIATRIC, REF DYNJ909547; 89) LEX DAVINCI PROSTATE, REF DYNJ909548A; 90) GYN-URO ROBOT, REF DYNJ910137A; 91) PROSTATECTOMY ROBOTIC, REF DYNJ910991; 92) GYN ROBOTIC, REF DYNJ910995; 93) ROBOTIC, REF DYNJ9225761X; 94) DAVINCI ROBOTIC PACK-LF, REF DYNJ9288198X; 95) MB GYN ROBOTIC ADD, REF DYNJ9701096M; 96) PHS722500FCK, REF PHS722500G.
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98197 |
| Address 1 | 3 Lakes Dr |
| Code info | REF CDS980523M: UDI/DI 10195327508913 (EA) 40195327508914 (CS), Lot number 25FBF036; REF CDS980523M: UDI/DI 10195327508913 (EA) 40195327508914 (CS), Lot number 25DBB218; REF CDS980647K: UDI/DI 10195327508920 (EA) 40195327508921 (CS), Lot number 25DBP829; REF CDS980647K: UDI/DI 10195327508920 (EA) 40195327508921 (CS), Lot number 25CBI860; REF CDS980864Q: UDI/DI 10198459121937 (EA) 40198459121938 (CS), Lot number 25EMC533; REF CDS981583U: UDI/DI 10195327209766 (EA) 40195327209767 (CS), Lot number 25CBC570; REF CDS981583V: UDI/DI 10198459311390 (EA) 40198459311391 (CS), Lot number 25FBK816; REF CDS981583V: UDI/DI 10198459311390 (EA) 40198459311391 (CS), Lot number 25EBS462; REF CDS981826K: UDI/DI 10198459224805 (EA) 40198459224806 (CS), Lot number 25FBH633; REF CDS981826K: UDI/DI 10198459224805 (EA) 40198459224806 (CS), Lot number 25BBU420; REF CDS982377K: UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25DMI839; REF CDS982377K: UDI/DI 10198459229039 (EA)... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 12584 units |
| Reason for recall | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251216 |
| Initial firm notification | Letter |
| Center classification date | 20260114 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3)...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableMedline Industries, LP
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionUS Nationwide distribution.
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Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Medline Industries, LP - Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K; 7) DEPAUL DAVINCI CDS, REF CDS982377K; 8) GU DAVINCI, REF CDS982779N; 9) GYN DAVINCI, REF CDS982780V; 10) UNIVERSAL ROBOTIC ORLANDO, REF CDS982857K; 11) ROBOTIC GU/GYN, REF CDS983393L; 12) GYN LAPAROSCOPY CDS, REF CDS984656Q; 13) GYN LAPAROSCOPY CDS, REF CDS984656R; 14) DAVINCI CDS UCC-LF, REF CDS984663J; 15) ROBOTIC UROLOGY PROSTATE, REF CDS985467J; 16) DAVINCI PROSTATECTOMY, REF DYNJG901002B; 17) ROBOTIC PACK IMF 100913- LF, REF DYNJVB91075C; 18) ROBOTIC PACK, REF DYNJ36840L; 19) ROBOTIC PACK MNMC, REF DYNJ38152D; 20) WMC GYN LAPAROSCOPY PACK-LF, REF DYNJ50649J; 21) ROBOTIC GASTRIC BYPASS PACK, REF DYNJ52096P; 22) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564D; 23) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564F; 24) GYN ROBOTIC PACK, REF DYNJ52581D; 25) GYN LAPAROSCOPY PACK, REF DYNJ53782J; 26) UNIVERSAL DAVINCI ROBOTIC P, REF DYNJ53968P; 27) WALKER GYN-UROLOGY ROBOTIC PK, REF DYNJ57458B; 28) GYN LAPAROSCOPY, REF DYNJ62136B; 29) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392F; 30) TOTAL LAPAROSCOPIC HYST PACK, REF DYNJ63456B; 31) ROBOTIC PACK, REF DYNJ67177D; 32) MH GYN LAPAROSCOPY PACK-LF, REF DYNJ84433B; 33) DAVINCI, REF DYNJ900963M; 34) LEX DAVINCI GYN MAJOR, REF DYNJ900965N; 35) LEX DAVINCI UROLOGY, REF DYNJ900967N; 36) COR DAVINCI, REF DYNJ901018O; 37) GYN ROBOTIC, REF DYNJ901046M; 38) DAVINCI, REF DYNJ901076L; 39) GYN ROBOTIC, REF DYNJ901796K; 40) LOU GENERAL ROBOT, REF DYNJ901844N; 41) LOU GYN LAPAROSCOPY, REF DYNJ901845L; 42) LOU GYN LAPAROSCOPY, REF DYNJ901845M; 43) LOU LITHOTOMY ROBOTIC, REF DYNJ901850N; 44) LEX GYN MINOR LAPAROSCOPY, REF DYNJ902029G; 45) GYN ROBOT, REF DYNJ902513J; 46) CHN OR DAVINCI PROSTATE, REF DYNJ902540O; 47) WMC ROBOTIC PACK - LF, REF DYNJ902583N; 48) ROBOTIC GYN & GU, REF DYNJ903459J; 49) GYN LAPAROSCOPY-LF, REF DYNJ903647I; 50) ROBOTIC UROLOGY, REF DYNJ903827F; 51) LITHOTOMY ROBOTIC CDS, REF DYNJ903948R; 52) GYN ROBOTIC, REF DYNJ903983P; 53) GYN LAP, REF DYNJ903990Q; 54) ROBOTIC-LF, REF DYNJ904254L; 55) ROBOTIC, REF DYNJ904343G; 56) ROBOT GYN, REF DYNJ904572L; 57) ROBOTIC PROSTECTOMY, REF DYNJ904597G; 58) GYN LAPAROSCOPY-LF, REF DYNJ905289G; 59) GYN ROBOTIC, REF DYNJ905730J; 60) URO ROBOTIC, REF DYNJ905746J; 61) COLON KIT, REF DYNJ905964G; 62) CHN OR ROBOTIC GYN, REF DYNJ905985O; 63) CW ROBOT, REF DYNJ906051C; 64) CW ROBOT, REF DYNJ906051D; 65) ROBOT, REF DYNJ906112B; 66) CDS ROBOTIC GYN CH, REF DYNJ906265D; 67) ROBOTIC GYN PACK, REF DYNJ906265F; 68) KIT GYN LAPAROSCOPY RFD, REF DYNJ906322F; 69) GYN LAPAROSCOPY, REF DYNJ906357C; 70) ROBOTIC COLON, REF DYNJ906379D; 71) GYN DAVINCI FOAKS, REF DYNJ906444C; 72) DAVINCI, REF DYNJ906543B; 73) CHN GYN ONCOLOGY, REF DYNJ906731K; 74) CHN ROBOTIC CYSTECTOMY, REF DYNJ907072F; 75) WMC THORACIC ROBOTIC, REF DYNJ907153C; 76) WMC THORACIC ROBOTIC, REF DYNJ907153D; 77) GYN ROBOTIC, REF DYNJ907492F; 78) KIT LAP GYN NTX, REF DYNJ907599C; 79) KIT ROBOTIC GYN, REF DYNJ907635D; 80) KIT ROBOTIC GYN, REF DYNJ907647B; 81) ROBOTIC-LF, REF DYNJ907910F; 82) ROBOTIC GENERAL, REF DYNJ907919C; 83) ROBOTIC BASE, REF DYNJ908447D; 84) ROBOTIC BASE, REF DYNJ908447F; 85) GYN, REF DYNJ908504A; 86) GU DAVINCI KIT, REF DYNJ908783F; 87) ROBOTIC PROSTATE, REF DYNJ909120D; 88) OSC ROBOT BARIATRIC, REF DYNJ909547; 89) LEX DAVINCI PROSTATE, REF DYNJ909548A; 90) GYN-URO ROBOT, REF DYNJ910137A; 91) PROSTATECTOMY ROBOTIC, REF DYNJ910991; 92) GYN ROBOTIC, REF DYNJ910995; 93) ROBOTIC, REF DYNJ9225761X; 94) DAVINCI ROBOTIC PACK-LF, REF DYNJ9288198X; 95) MB GYN ROBOTIC ADD, REF DYNJ9701096M; 96) PHS722500FCK, REF PHS722500G. Check if your household is affected: https://therecallfile.com/es/recalls/medline-medical-procedure-convenience-kits-labeled-as-1-robotic-ref-cd/FDA-Z-1088-2026
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