Pre-op kits recalled because they contain recalled B. Braun administration sets
Medline is recalling 32 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a supplier component recall over stuck check valves with no stated consequence or reported harm.
Plain-English summary
Medline kits containing B. Braun IV Administration Sets and Pump Administration Sets are being recalled by Medline Industries, LP, covering the Deluxe Pre Op Kit under Medline SKUs DYKS2034A and DYKS2006B.
The 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.
The record lists 32 units, with kit SKUs, UDI/DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The record describes a component recalled at the supplier and states no further consequence or reported injuries. Facilities should quarantine affected kits and follow Medline's instructions.
The recalled product
- 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.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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