Medline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
Medline is recalling 235 surgical convenience kits 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 2/5 (Moderate).
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: The recall is classified as Class II because the non-conforming cannula components may cause temporary or medically reversible adverse health consequences, such as leaking or breaking during use. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 235 surgical convenience kits labeled as CV BASIN PACK-LF. The affected products include Medline Product Numbers/SKUs DYNJ0538615K, DYNJ0538615J, and DYNJ0538615L. These kits were distributed nationwide in the United States.
The recall was initiated because the kits contain cannula components that do not conform to ISO 80369-7 dimensional requirements. This non-conformance may contribute to the components leaking or breaking during use. The source text does not report any illnesses, injuries, or deaths associated with these products.
Healthcare facilities and consumers should stop using the affected kits and contact Medline Industries, LP for further instructions or a replacement.
The recalled product
- Product
- Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J; 3) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615L.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 235
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 (13)
- Medline Product Number/SKU DYNJ0538615L
- UDI/DI 10198459414152 (each) 40198459414153 (case)
- Lot number 26BBA206
- Lot number 25LBQ023
- Lot number 25KBR149
- Medline Product Number/SKU DYNJ0538615K
- UDI/DI 10198459136429 (each) 40198459136420 (case)
- Lot number 25EBF588
- Lot number 25ABI296
- Lot number 24IBP190
- Medline Product Number/SKU DYNJ0538615J
- UDI/DI 10195327673376 (each) 40195327673377 (case)
- Lot number 24DBC864.
Distribution
Distributed nationwide across the United States.
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