Venclose recall
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Why was Venclose recalled?
Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component #137339 - SET INTRO 6.5FX12CM FITS 0.018, instead of a 7cm introducer/sheath, component #137340 - SET INTRO 6.5FX7CM FITS 0.018
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 40193489423090, lot number 22EBV345, exp. 08/31/2024; UDI/DI 10193489423099, lot number 22FBF358, exp. 08/31/2024
- Product
- VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1760 kits
- Distribution
- CA
- Recall date
- October 19, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)