Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product
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: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC; 2) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AB; 3) CATH LAB ENDO AAA, Medline product number/SKU DYNJ35312I; 4)…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
- Affected units
- 472
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)
- Medline product number/SKU DYNJ0656274AC
- UDI/DI 10195327517311 (each) 40195327517312 (case)
- lot number 25GME600
- lot number 25DMJ601
- lot number 25CMA596
- lot number 24FMB407
- lot number 24CMH524
- lot number 23LMF661
- lot number 23JME256
- Medline product number/SKU DYNJ0656274AB
- UDI/DI 10193489857900 (each) 40193489857901 (case)
- lot number 23GMB142
- lot number 23FMH674
- lot number 23BMC121
- lot number 23AMB446
- lot number 22KMG366
- lot number 22GMB609
- Medline product number/SKU DYNJ35312I
- UDI/DI 10193489481877 (each) 40193489481878 (case)
- lot number 22DDA108
Distribution
Distributed nationwide across the United States.
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