Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Model Number: DYNJ0547084O; 6) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 7) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 8) VAG HYST PACK, Model Number: DYNJ31344J; 9) VAG HYST PACK, Model Number: DYNJ31344K; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 12) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 13) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 14) LAVH PACK, Model Number: DYNJ36712F; 15) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 16) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 17) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 18) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 19) LAVH - N #668629 -N, Model Number: DYNJ58121C; 20) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 21) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 22) D AND C PACK, Model Number: DYNJ61282B; 23) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 24) PERI GYN, Model Number: DYNJ67708A; 25) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 26) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 27) ANORECTAL PACK, Model Number: DYNJ83560; 28) D&C CDS, Model Number: DYNJ902560I; 29) HYSTEROSCOPY, Model Number: DYNJ903327K; 30) HYSTEROSCOPY, Model Number: DYNJ903475I; 31) ROBOTIC HYST, Model Number: DYNJ903798G; 32) TLH KIT, Model Number: DYNJ908149; 33) LAVH TOTE, Model Number: DYNJ908340; 34) LAVH TOTE, Model Number: DYNJ908340A; 35) LAVH TOTE, Model Number: DYNJ908340B; 36) LAVH TOTE, Model Number: DYNJ908340D; 37) LAVH, Model Number: DYNJ908986; 38) LAVH, Model Number: DYNJ908986A; 39) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 40) LAVH GYN/ONC, Model Number: DYNJ910927; 41) VAG HYST PACK, Model Number: DYNJT3348; 42) LAVH PART B, Model Number: DYNJV0312G
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Model Number: DYNJ0547084O; 6) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 7) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 8) VAG HYST PACK, Model Number: DYNJ31344J; 9) VAG HYST PACK, Model Number: DYNJ31344K; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 12) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 13) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 14) LAVH PACK, Model Number: DYNJ36712F; 15) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 16) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 17) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 18) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 19) LAVH - N #668629 -N, Model Number: DYNJ58121C; 20) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 21) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 22) D AND C PACK, Model Number: DYNJ61282B; 23) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 24) PERI GYN, Model Number: DYNJ67708A; 25) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 26) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 27) ANORECTAL PACK, Model Number: DYNJ83560; 28) D&C CDS, Model Number: DYNJ902560I; 29) HYSTEROSCOPY, Model Number: DYNJ903327K; 30) HYSTEROSCOPY, Model Number: DYNJ903475I; 31) ROBOTIC HYST, Model Number: DYNJ903798G; 32) TLH KIT, Model Number: DYNJ908149; 33) LAVH TOTE, Model Number: DYNJ908340; 34) LAVH TOTE, Model Number: DYNJ908340A; 35) LAVH TOTE, Model Number: DYNJ908340B; 36) LAVH TOTE, Model Number: DYNJ908340D; 37) LAVH, Model Number: DYNJ908986; 38) LAVH, Model Number: DYNJ908986A; 39) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 40) LAVH GYN/ONC, Model Number: DYNJ910927; 41) VAG HYST PACK, Model Number: DYNJT3348; 42) LAVH PART B, Model Number: DYNJV0312G
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Loard's Brownie Nut Fudge Ice Cream - 32 oz
Loard's Brownie Nut Fudge Ice Cream - 32 oz
Undeclared Milk, Walnuts, Eggs, Wheat, Soy.
Loard's Lemon Chiffon Ice Cream - 32 oz
Loard's Lemon Chiffon Ice Cream - 32 oz
Undeclared Milk, Eggs, Yellow #5.
Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069
Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHEET,DRAPE,53X77,STERILE, Model Number: DYNJP2414; 6) DRAPE,SHEET,3/4,53X77",ST,20/CS, Model Number: DYNJP2414R; 7) DRAPE,SHEET,ULTRAGARD,20/CS, Model Number: DYNJP2414UG; 8) DRAPE,RNF,53X77",ST,20/CS, Model Number: DYNJP2416; 9) SHEET,DRAPE,70X85,STERILE, Model Number: DYNJP2417; 10) DRAPE,FILM SHEET,44X65",ST,20/CS, Model Number: DYNJP2418; 11) DRAPE,SHEET,70X100",ST,12/CS, Model Number: DYNJP2419; 12) LEGGINGS,33X49",XL,PAIR,ST,CLR,20/CS, Model Number: DYNJP2462; 13) DRAPE,CHEST,FENESTRATION,15X10",ST,12/CS, Model Number: DYNJP2491; 14) DRAPE,MINOR PROC,6X6" FEN, ST,10/CS, Model Number: DYNJP2492; 15) SHEET, DRAPE, SPLIT, ST,10/CS, Model Number: DYNJP2498; 16) DRAPE,LAPAROTOMY,T-SHEET,ST,12/CS, Model Number: DYNJP3003; 17) DRAPE,LAPAROTOMY,T,ULTRAGARD,12/CS, Model Number: DYNJP3003UG; 18) DRAPE,LAPAROTOMY,POUCH,ST,12/CS, Model Number: DYNJP3008; 19) DRAPE,LAPAROTOMY,POUCH ULTRAGARD,12/CS, Model Number: DYNJP3008UG; 20) DRAPE,LAPAROTOMY,T,PEDIATRIC,ST,10/CS, Model Number: DYNJP3009; 21) DRAPE,LAPAROTOMY,ABDOMINAL,ST,12/CS, Model Number: DYNJP3101; 22) DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS, Model Number: DYNJP3102A; 23) DRAPE,LAP,CHOLE,W/TROUGH ULTRAGARD,12/CS, Model Number: DYNJP3102UG; 24) DRAPE,ABDOMINAL,MAJOR,ST,8/CS, Model Number: DYNJP3103; 25) DRAPE,ABDOMINAL,MAJOR,PCH/TRGH,ST,8/CS, Model Number: DYNJP3109; 26) DRAPE,TOP,102X53",ST,14/CS, Model Number: DYNJP4002; 27) DRAPE,CARDIOVASCULAR,SPLIT,ST,8/CS, Model Number: DYNJP4003; 28) DRAPE,ANGIO,BRACH,ECLIPSE,38X44,ST,40/CS, Model Number: DYNJP4106; 29) DRAPE,FEMORAL ANGIOGRAPHY,W/POUCH,8/CS, Model Number: DYNJP4119; 30) DRAPE,TOP,ARMCOVERS,106X59,STERILE,20/CS, Model Number: DYNJP4215; 31) DRAPE,UNDERBUTTOCK,PCH,ST,20/CS, Model Number: DYNJP6002; 32) DRAPE,UNDERBUTTOCK,GRAD POUCH,PORT,20/CS, Model Number: DYNJP6006; 33) DRAPE,EENT,SPLIT,ST,8/CS, Model Number: DYNJP7001; 34) SHEET,T,THYROID,ST,12/CS, Model Number: DYNJP7003; 35) DRAPE,EXTREMITY,89X128",ST,12/CS, Model Number: DYNJP8002; 36) DRAPE,EXTREMITY,ULTRAGARD,12/CS, Model Number: DYNJP8002UG; 37) T-DRAPE,EXTREMITY,ST,6/CS, Model Number: DYNJP8003; 38) T-DRAPE,EXTREMITY,ULTRAGARD,6/CS, Model Number: DYNJP8003UG; 39) DRAPE,HAND,ST,18/CS, Model Number: DYNJP8005; 40) DRAPE,HAND,ULTRAGARD,18/CS, Model Number: DYNJP8005UG; 41) DRAPE,HIP,W/POUCH,ST,5/CS, Model Number: DYNJP8201; 42) DBD-DRAPE,HIP,W/POUCHES, ULTRAGARD, Model Number: DYNJP8201UG; 43) DRAPE,ORTHOMAX,HIP,W/POUCH,6/CS, Model Number: DYNJP8211; 44) SHEET,ORTHO,SPLIT,ST,10/CS, Model Number: DYNJP8301; 45) DRAPE,SPLIT,77X120",10/CS, Model Number: DYNJP8304A; 46) ULTRAGARD SPLIT DRAPE,10/CS, Model Number: DYNJP8304UG; 47) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8412; 48) DRAPE,SHOULDER,BEACH CH,ULTRAGARD,5/CS, Model Number: DYNJP8412UG; 49) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8414; 50) DRAPE,LITHOTOMY,ST,8/CS, Model Number: DYNJP9001; 51) DRAPE,LAVH,ST,8/CS, Model Number: DYNJP9103; 52) DRAPE,VETERINARY,CUSTOM,SM,20/CS, Model Number: MED901; 53) DRAPE,VETERINARY,CUSTOM,M,20/CS, Model Number: MED902; 54) DRAPE,VETERINARY,CUSTOM,L,20/CS, Model Number: MED903
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHEET,DRAPE,53X77,STERILE, Model Number: DYNJP2414; 6) DRAPE,SHEET,3/4,53X77",ST,20/CS, Model Number: DYNJP2414R; 7) DRAPE,SHEET,ULTRAGARD,20/CS, Model Number: DYNJP2414UG; 8) DRAPE,RNF,53X77",ST,20/CS, Model Number: DYNJP2416; 9) SHEET,DRAPE,70X85,STERILE, Model Number: DYNJP2417; 10) DRAPE,FILM SHEET,44X65",ST,20/CS, Model Number: DYNJP2418; 11) DRAPE,SHEET,70X100",ST,12/CS, Model Number: DYNJP2419; 12) LEGGINGS,33X49",XL,PAIR,ST,CLR,20/CS, Model Number: DYNJP2462; 13) DRAPE,CHEST,FENESTRATION,15X10",ST,12/CS, Model Number: DYNJP2491; 14) DRAPE,MINOR PROC,6X6" FEN, ST,10/CS, Model Number: DYNJP2492; 15) SHEET, DRAPE, SPLIT, ST,10/CS, Model Number: DYNJP2498; 16) DRAPE,LAPAROTOMY,T-SHEET,ST,12/CS, Model Number: DYNJP3003; 17) DRAPE,LAPAROTOMY,T,ULTRAGARD,12/CS, Model Number: DYNJP3003UG; 18) DRAPE,LAPAROTOMY,POUCH,ST,12/CS, Model Number: DYNJP3008; 19) DRAPE,LAPAROTOMY,POUCH ULTRAGARD,12/CS, Model Number: DYNJP3008UG; 20) DRAPE,LAPAROTOMY,T,PEDIATRIC,ST,10/CS, Model Number: DYNJP3009; 21) DRAPE,LAPAROTOMY,ABDOMINAL,ST,12/CS, Model Number: DYNJP3101; 22) DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS, Model Number: DYNJP3102A; 23) DRAPE,LAP,CHOLE,W/TROUGH ULTRAGARD,12/CS, Model Number: DYNJP3102UG; 24) DRAPE,ABDOMINAL,MAJOR,ST,8/CS, Model Number: DYNJP3103; 25) DRAPE,ABDOMINAL,MAJOR,PCH/TRGH,ST,8/CS, Model Number: DYNJP3109; 26) DRAPE,TOP,102X53",ST,14/CS, Model Number: DYNJP4002; 27) DRAPE,CARDIOVASCULAR,SPLIT,ST,8/CS, Model Number: DYNJP4003; 28) DRAPE,ANGIO,BRACH,ECLIPSE,38X44,ST,40/CS, Model Number: DYNJP4106; 29) DRAPE,FEMORAL ANGIOGRAPHY,W/POUCH,8/CS, Model Number: DYNJP4119; 30) DRAPE,TOP,ARMCOVERS,106X59,STERILE,20/CS, Model Number: DYNJP4215; 31) DRAPE,UNDERBUTTOCK,PCH,ST,20/CS, Model Number: DYNJP6002; 32) DRAPE,UNDERBUTTOCK,GRAD POUCH,PORT,20/CS, Model Number: DYNJP6006; 33) DRAPE,EENT,SPLIT,ST,8/CS, Model Number: DYNJP7001; 34) SHEET,T,THYROID,ST,12/CS, Model Number: DYNJP7003; 35) DRAPE,EXTREMITY,89X128",ST,12/CS, Model Number: DYNJP8002; 36) DRAPE,EXTREMITY,ULTRAGARD,12/CS, Model Number: DYNJP8002UG; 37) T-DRAPE,EXTREMITY,ST,6/CS, Model Number: DYNJP8003; 38) T-DRAPE,EXTREMITY,ULTRAGARD,6/CS, Model Number: DYNJP8003UG; 39) DRAPE,HAND,ST,18/CS, Model Number: DYNJP8005; 40) DRAPE,HAND,ULTRAGARD,18/CS, Model Number: DYNJP8005UG; 41) DRAPE,HIP,W/POUCH,ST,5/CS, Model Number: DYNJP8201; 42) DBD-DRAPE,HIP,W/POUCHES, ULTRAGARD, Model Number: DYNJP8201UG; 43) DRAPE,ORTHOMAX,HIP,W/POUCH,6/CS, Model Number: DYNJP8211; 44) SHEET,ORTHO,SPLIT,ST,10/CS, Model Number: DYNJP8301; 45) DRAPE,SPLIT,77X120",10/CS, Model Number: DYNJP8304A; 46) ULTRAGARD SPLIT DRAPE,10/CS, Model Number: DYNJP8304UG; 47) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8412; 48) DRAPE,SHOULDER,BEACH CH,ULTRAGARD,5/CS, Model Number: DYNJP8412UG; 49) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8414; 50) DRAPE,LITHOTOMY,ST,8/CS, Model Number: DYNJP9001; 51) DRAPE,LAVH,ST,8/CS, Model Number: DYNJP9103; 52) DRAPE,VETERINARY,CUSTOM,SM,20/CS, Model Number: MED901; 53) DRAPE,VETERINARY,CUSTOM,M,20/CS, Model Number: MED902; 54) DRAPE,VETERINARY,CUSTOM,L,20/CS, Model Number: MED903
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Loard's Mocha Chip Ice Cream - 32 oz; 56 oz
Loard's Mocha Chip Ice Cream - 32 oz; 56 oz
Undeclared Milk.
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Loard's Coffee Ice Cream - 32 oz
Loard's Coffee Ice Cream - 32 oz
Undeclared Milk.
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Respiratory/sore throat panel test may result in false negative results and control failures.
Loard's Raspberry Sherbert - 32 oz
Loard's Raspberry Sherbert - 32 oz
Undeclared Milk, Red #40.
See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M;
See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M;
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP TRAY, Model Number:DYNJRA1979B; 7) VARITHENA TRAY 2, Model Number:DYNJRA2608; 8) CPNB SETUP TRAY, Model Number:SAMPA0108
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP TRAY, Model Number:DYNJRA1979B; 7) VARITHENA TRAY 2, Model Number:DYNJRA2608; 8) CPNB SETUP TRAY, Model Number:SAMPA0108
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Loard's Cookies and Cream Ice Cream - 32 oz; 56 oz
Loard's Cookies and Cream Ice Cream - 32 oz; 56 oz
Undeclared Milk, Wheat, Soy.
See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B;
See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B;
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Lemon Creamed Honey, 671333101353 *These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101353
Lemon Creamed Honey, 671333101353 *These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101353
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Loard's Chocolate Showers Ice Cream - 32 oz; 56 oz
Loard's Chocolate Showers Ice Cream - 32 oz; 56 oz
Undeclared Milk, Soy.
Loard's Banana Ice Cream - 32 oz; 56 oz
Loard's Banana Ice Cream - 32 oz; 56 oz
Undeclared Milk, Yellow #5.
Loard's Toasted Almond Ice Cream - 32 oz
Loard's Toasted Almond Ice Cream - 32 oz
Undeclared Milk, Almonds.
Hiab USA Inc. - Liftgate Deck Pins May Break
Hiab USA Inc. - Liftgate Deck Pins May Break
A liftgate that falls unexpectedly increases the risk of injury.