Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) AR...
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) 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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98329 |
| Address 1 | 3 Lakes Dr |
| Code info | 1) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 23BBL738; 2) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 23BBJ847; 3) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22IBF936; 4) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22IBE795; 5) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22FBP788; 6) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22BBD031; 7) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22ABJ831; 8) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 21JBJ732; 9) DYNJ22501G, UDI-DI: 10889942234110(each), 40889942234111(case), Lot Number: 21CBZ902; 10) DYNJ22501G, UDI-DI: 10889942234110(each), 40889942234111(case), Lot Number: 21ABK153; 11) DYNJ32715F, UDI-DI: 10889942530038(each), 40889942530039(case), Lot Number: 21ADB529; 12) DYNJ50834C, UDI... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260225 |
| Product type | Devices |
| Product quantity | 175 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.