MEDLINE Burn Convenience Kits Recalled Due to Defective Component
MEDLINE is recalling 486 burn convenience kits because they were manufactured using SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.
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: This is a Class II FDA recall with no reported hospitalizations, injuries, or illnesses. The recall is precautionary and secondary, based solely on the use of a component previously recalled by another manufacturer.
Plain-English summary
MEDLINE INDUSTRIES, LP is recalling 486 burn convenience kits that were distributed nationwide. The recall involves three product variants: BURN kits (REF CDS983465M and CDS983465N) and BURN PACK (REF DYNJ63331D).
These convenience kits were manufactured using SafeAir Smoke Evacuation Pencil components from lot numbers that were previously recalled by Stryker, the manufacturer of the pencil component. The use of these recalled components triggered this secondary recall of the MEDLINE kits.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Hazard
- Affected units
- 486
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 (14)
- 1) REF CDS983465N
- UDI/DI 10195327497309 (each) 40195327497300 (case)
- Lot Numbers: 24CDB460
- 24BDA880
- 23KDB948
- 2)REF CDS983465N
- UDI/DI 10195327699987 (each) 40195327699988 (case)
- Lot Numbers: 24EDB092
- 24EDA519
- 3) REF DYNJ63331D
- UDI/DI UDI/DI 10195327270346 (each) 40195327270347 (case)
- Lot Numbers: 23LME440
- 23HMI168
- 23KMD370
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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