See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVE...
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
See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326B; 4) DRAWER #5, Model Number: ACC010475; 5) DRAWER 1 NEURO CART, Model Number: ACC010542; 6) DRAWER 2 NEURO CART, Model Number: ACC010543; 7) DRAWER 4, Model Number: ACC010722; 8) SUCTION TRAY, Model Number: ACC010862; 9) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896;
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98642 |
| Address 1 | 3 Lakes Dr |
| Code info | 1) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21CDB175; 2) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21CDB692; 3) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21LDA438; 4) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22BDB172; 5) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22HDA973; 6) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 23ADA426; 7) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 23BDA230; 8) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 23CDC052; 9) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23CDA732; 10) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23IDB293; 11) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23LDB309; 12) ACC010326A, UDI-DI: 101... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 207196 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.