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.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Undeclared tree nut allergens: almonds, pecans, and walnuts."
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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