Medline Venclose cardiovascular procedure kits recalled for wrong component size
Medline Industries is recalling 1,760 Venclose procedure packs due to incorrect introducer/sheath component size. Affected kits contain 12cm components instead of the required 7cm.
What this means for you
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: This is a Class II medical device recall involving a critical cardiovascular procedure component with incorrect specifications. While no illnesses or injuries have been reported, the component size discrepancy constitutes a risk-of-harm scenario where the wrong-sized introducer could affect procedure success and patient safety.
Plain-English summary
Medline Industries, LP is recalling 1,760 Venclose Procedure Pack kits (Model 7VM, Ref VC-PPH-67A) distributed in California. These are cardiovascular procedure convenience kits used in medical settings.
The recalled kits contain incorrect introducer/sheath components. Specifically, affected kits include either a 12cm introducer/sheath (component #128626 or #137339) instead of the correct 7cm introducer/sheath (component #137340).
Healthcare providers and facilities with these kits should discontinue use and contact Medline Industries for return or replacement instructions. The affected lot numbers are 22EBV345 and 22FBF358, both with expiration dates of 08/31/2024. The kits are identified by UDI/DI codes 40193489423090 and 10193489423099.
The recalled product
- Product
- VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 1,760
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 (5)
- UDI/DI 40193489423090
- lot number 22EBV345
- exp. 08/31/2024
- UDI/DI 10193489423099
- lot number 22FBF358
Distribution
Distributed in 1 state:
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