Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT G...
Reason for Recall / Hazard
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.
Product Description & Identification
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) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 6) VAG HYST PACK, Model Number: DYNJ31344J; 7) VAG HYST PACK, Model Number: DYNJ31344K; 8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 12) LAVH PACK, Model Number: DYNJ36712F; 13) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 14) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 15) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 16) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 17) LAVH - N #668629 -N, Model Number: DYNJ58121C; 18) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 19) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 20) D AND C PACK, Model Number: DYNJ61282B; 21) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 22) PERI GYN, Model Number: DYNJ67708A; 23) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 24) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 25) ANORECTAL PACK, Model Number: DYNJ83560; 26) D&C CDS, Model Number: DYNJ902560I; 27) HYSTEROSCOPY, Model Number: DYNJ903327K; 28) ROBOTIC HYST, Model Number: DYNJ903798G; 29) TLH KIT, Model Number: DYNJ908149; 30) LAVH TOTE, Model Number: DYNJ908340; 31) LAVH TOTE, Model Number: DYNJ908340A; 32) LAVH TOTE, Model Number: DYNJ908340B; 33) LAVH TOTE, Model Number: DYNJ908340D; 34) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 35) VAG HYST PACK, Model Number: DYNJT3348; 36) LAVH PART B, Model Number: DYNJV0312G
Affected Products
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) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 6) VAG HYST PACK, Model Number: DYNJ31344J; 7) VAG HYST PACK, Model Number: DYNJ31344K; 8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 12) LAVH PACK, Model Number: DYNJ36712F; 13) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 14) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 15) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 16) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 17) LAVH - N #668629 -N, Model Number: DYNJ58121C; 18) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 19) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 20) D AND C PACK, Model Number: DYNJ61282B; 21) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 22) PERI GYN, Model Number: DYNJ67708A; 23) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 24) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 25) ANORECTAL PACK, Model Number: DYNJ83560; 26) D&C CDS, Model Number: DYNJ902560I; 27) HYSTEROSCOPY, Model Number: DYNJ903327K; 28) ROBOTIC HYST, Model Number: DYNJ903798G; 29) TLH KIT, Model Number: DYNJ908149; 30) LAVH TOTE, Model Number: DYNJ908340; 31) LAVH TOTE, Model Number: DYNJ908340A; 32) LAVH TOTE, Model Number: DYNJ908340B; 33) LAVH TOTE, Model Number: DYNJ908340D; 34) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 35) VAG HYST PACK, Model Number: DYNJT3348; 36) LAVH PART B, Model Number: DYNJV0312G
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98329 |
| Address 1 | 3 Lakes Dr |
| Code info | 1) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24CBQ563; 2) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24ABO363; 3) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23IBV204; 4) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23HBY878; 5) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23GBE705; 6) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23HBI773; 7) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBD256; 8) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBC116; 9) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBS135; 10) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBL440; 11) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH451; 12) DYKMBNDL9... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260225 |
| Product type | Devices |
| Product quantity | 4415 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260107 |
| Initial firm notification | Letter |
| Center classification date | 20260217 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide.