IV start kits recalled over recalled B. Braun administration sets inside
Medline is recalling 5314 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 IV Start Kit NS under Medline kit SKU DYKM1980C, (134) L&D IV-Start Set under SKU DYKM2137B and IV Start Kit under SKU DYKS1372C, among the 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 5314 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) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B; 3) IV START KIT, Medline kit SKU DYKS1372C; 4) IV START KIT, Medline…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 5,314
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 kit SKU DYKM1980C
- UDI/DI 10195327608309 (EA) 40195327608300 (CS)
- Lot Number 25JBB147
- Lot Number 25KBL305
- Medline kit SKU DYKM2137B
- UDI/DI 10198459285615 (EA) 40198459285616 (CS)
- Lot Number 25HBT834
- Lot Number 25IBJ757
- Lot Number 25JBJ557
- Medline kit SKU DYKS1372C
- UDI/DI 10195327373504 (EA) 40195327373505 (CS)
- Lot Number 25JLA480
- Medline kit SKU DYNDV1691B
- UDI/DI 10195327658472 (EA) 40195327658473 (CS)
- Lot Number 25HBI335
- Lot Number 25IBE523
- Lot Number 25JBM702
- Medline kit SKU DYNDV2464A
- UDI/DI 10195327065911 (EA) 40195327065912 (CS)
- Lot Number 25IBV942.
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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