ROTAWIRE Drive and wireClip Torquer recall: Sterility Concern
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Why was ROTAWIRE Drive and wireClip Torquer recalled?
Pouch seals may be open, compromising sterility.
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?
ROTAWIRE Drive Extra Support, 5 pack, UPN: H74939463005 Individual units within 5-pack are labeled as Single, UPN: H74939463001 Batch numbers: 27630467, 27632712, 27701910, 27705926, 27749752, 27749754, 27792970 27804244, 27805109, 27806091, 27826574, 27826576, 27853736, 27853738, and 27862767 GTIN: 08714729996231
- Product
- ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 488 5-packs
- Distribution
- Distribution in the US and territories, Japan, and Canada
- Recall date
- April 20, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)