Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ4
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking 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
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
The recalled product
- Product
- Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
- Affected units
- 3,125
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)
- UDI/DI 10193489461725 (each) 40193489461726 (case)
- Lot Numbers: 25LMF813
- 25IMF341
- 25HBR484
- 25FBP179
- 25EBJ732
- 25DBK745
- 25CBK191
- 25BBE801
- 24LBB945
- 24IBT658
- 24IBD265
- 24GBG100
- 24EBC752
- 24CBQ893
- 24BBJ088
- 24ABE008
- 23JBA374
- 23HBV035
- 23GBL681
Distribution
Distributed nationwide across the United States.
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