Medline surgical kits recalled for non-conforming cannula components
Medline is recalling 56 surgical convenience kits because the cannula components may leak or break during use.
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 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 recall is classified as FDA Class II, and the source identifies a hazard where cannula components may leak or break during use. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 56 surgical convenience kits labeled as VEIN HARVESTING PACK, product number DYNJ51845D. The kits were distributed nationwide in the United States.
The recall was issued because the kits contain cannula components that do not conform to ISO 80369-7 dimensional requirements. These non-conforming components may contribute to leaking or breaking during use.
The affected kits have UDI/DI 10195327005412 (each) and 40195327005413 (case), and Lot number 23JMA378. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled product.
The recalled product
- Product
- Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845D
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 56
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 (2)
- UDI/DI 10195327005412 (each) 40195327005413 (case)
- Lot number 23JMA378
Distribution
Distributed nationwide across the United States.
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