Device product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.
Z-1051-2026
Product summary
- Event
- Event 98154
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32 units
- Official record key
device-enforcement:Z-1051-2026
Official wording
Reason: 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.
Code information: Medline kit SKU PHS972096014B UDI/DI: 10889942695911 (EA) 40889942695912 (CS), Lot Number 25IBT843; Medline kit SKU CDS984289O UDI/DI: 10198459418143 (EA) 40198459418144 (CS), Lot Number 25IMA327; Medline kit SKU DYNJ903523F UDI/DI: 10198459316593 (EA) 40198459316594 (CS), Lot Number 25IMI028.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.