ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
- Company
- Boston Scientific Corporation
- Recall Initiated
- March 8, 2022
- Recall Number
- Z-0916-2022
- Quantity
- 488 5-packs
- Firm Location
- Maple Grove, MN
Reason for Recall
Pouch seals may be open, compromising sterility.
Distribution
Distribution in the US and territories, Japan, and Canada
Lot / Code Info
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
Root Cause
Process control
Action Taken
US consignees were mailed an overnight delivery of the customer letter. OUS consignees will be contacted by letter delivery or email. Accounts are asked to return any unused affected devices to the recalling firm. The customer letter provides customers with the product segregation and return instructions and accounts are asked to complete a Reply Verification Tracking Form indicating that they have received the field removal and followed the included instructions.