Open heart kits recalled because they contain recalled B. Braun administration sets
Medline is recalling 633 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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 Open Heart Accessory CDS Kit (SKU CDS984289O), Open Heart CDS Kit (SKU CDS984355K), Bag A Open Heart Kit (SKU DYKM1025D) and RR-CABG supply kits among other kits listed in the enforcement record.
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 633 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) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 633
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 (20)
- Medline SKU PHS972096014B
- UDI/DI 10889942695911 (EA) 40889942695912 (CS)
- Lot Number 25GBY100
- Medline SKU CDS984289O
- UDI/DI 10198459418143 (EA) 40198459418144 (CS)
- Lot Number 25HBI736
- Medline SKU DYNJ903523F
- UDI/DI 10198459316593 (EA) 40198459316594 (CS)
- Lot Number 25HBL296
- Lot Number 25HBN030
- Medline SKU DYNJ902879T
- UDI/DI 10195327461294 (EA) 40195327461295 (CS)
- Lot Number 25HLA445
- Medline SKU DYKM1025D
- UDI/DI 10195327482893 (EA) 40195327482894 (CS)
- Lot Number 25HMA140
- Medline SKU DYNJ0394752O
- UDI/DI 10193489432794 (EA) 40193489432795 (CS)
- Lot Number 25IBI197
- Lot Number 25IBL774
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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