Medline Recalls Surgical Kits With Non-Conforming Cannula Components
Medline Industries is recalling 8,374 surgical convenience kits nationwide because the cannula components do not meet ISO 80369-7 dimensional requirements and 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a Class II medical device where cannula components may leak or break during use, posing a risk of harm. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 8,374 surgical convenience kits distributed nationwide. The affected products include various vascular and vein harvesting packs, such as the VEIN HARVESTING PACK-LF, NBMC VASCULAR PACK-LF, and AV FISTULA kits, identified by specific Medline product numbers and lot numbers.
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 source text does not report any illnesses, injuries, or deaths associated with the use of these products.
Healthcare facilities and consumers should stop using the affected kits and contact Medline Industries for further instructions on returns or replacements.
The recalled product
- Product
- Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J; 2) NBMC VASCULAR PACK-LF, Medline product number/SKU DYNJ0665837G; 3) AV FISTULA, Medline product number/SKU DYNJ900454C; 4) VEIN PACK SHD, Medline product…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 8,374
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 DYNJ0826732J
- UDI/DI 10198459008764 (each) 40198459008765 (case)
- Lot Number 26BMB707
- Medline product number/SKU DYNJ0665837G
- UDI/DI 10198459543685 (each) 40198459543686 (case)
- Lot Number 26BBG404
- Medline product number/SKU DYNJ900454C
- UDI/DI 10193489857108 (each) 40193489857109 (case)
- Lot Number 26AMI490
- Medline product number/SKU DYNJ68420D
- UDI/DI 10195327341718 (each) 40195327341719 (case)
- Lot Number 26ABM059
- Lot Number 26ABC613
- Medline product number/SKU DYNJ905692J
- UDI/DI 10198459298479 (each) 40198459298470 (case)
- Lot Number 25LDB280
- Medline product number/SKU DYNJ908620D
- UDI/DI 10198459434402 (each) 40198459434403 (case)
- Lot Number 25LBA755
- Lot Number 25KMJ136
Distribution
Distributed nationwide across the United States.
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