Halyard SUTURE PACK CABG. Cardiovascular Procedure recall
Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
Why was Halyard SUTURE PACK CABG. Cardiovascular Procedure recalled?
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Model No. SILV800-01; UDI: 10809160450680; Lot Code: Lot: 1642454; Exp: 2/4/2028.
- Product
- Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 60 units
- Distribution
- US Nationwide distribution in the states of IL & LA.
- Recall date
- May 21, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)