Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI430...
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) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 6) NICU LINE CHANGE TRAY, Model Number: LC295
Affected Products
Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 6) NICU LINE CHANGE TRAY, Model Number: LC295
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98642 |
| Address 1 | 3 Lakes Dr |
| Code info | 1) CVI4300, UDI-DI: 10653160294313(each), 653160294316(case), Lot Number: 2020120950; 2) DYKM1977C, UDI-DI: 10653160381105(each), 653160381108(case), Lot Number: 2024110190; 3) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21ABC197; 4) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21ABJ543; 5) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21BBB580; 6) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA391; 7) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA391Z; 8) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA621; 9) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21DLA326; 10) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21ELA080; 11) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21FLA214; 12) DYK... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 553 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 | 20260507 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution.