Mandible and ear procedure packs recalled over recalled B. Braun sets
Medline is recalling 96 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 RR-Le Fort Mandible Pack-LF under Medline kit SKU DYNJ0785864R and the RR-ASC Ear Pack-LF under SKU DYNJ0792607R.
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 96 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
- Atwater's, Holiday Cookie Tin, 19.65 ounces, Round metal tin with a window lid
- Manufacturer
- One Roof LLC
- Category
- Medical Device — Procedure kit
- Affected units
- 197
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 (1)
- no code
Distribution
Distributed in 1 state:
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