FDA DevicesClass II
Medline Kits containing B. Braun IV Administration Sets and Pump Administration ...
Published: January 21, 2026Recall ID: Z-1053-2026Category: devicesCountry: US
Reason for Recall / Hazard
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Product Description & Identification
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
Affected Products
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98154 |
| Address 1 | 3 Lakes Dr |
| Code info | UDI/DI 10195327634698 (EA) 40195327634699 (CS), Lot numbers: 25HLA435, 25HLB046. |
| Postal code | 60093-2753 |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 33 units |
| Reason for recall | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251126 |
| Initial firm notification | Letter |
| Center classification date | 20260112 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.