WhichRecall
Class IIReported 2026-01-21

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.

Recalled by Medline Industries, LP

Reason for Recall

Medline kits contain B

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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.

Recall Number
Z-1051-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-26
Reported
2026-01-21
Distribution
US Nationwide distribution.
Code Info
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.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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