Z-0916-2022 Class II Ongoing
FDA device recall Z-0916-2022 was initiated by Boston Scientific Corporation on Mar 8, 2022 and is designated Class II. Reason for recall: Pouch seals may be open, compromising sterility. The recall status is ongoing. Affected quantity: 488 5-packs.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 20, 2022
- Initiation Date
- Mar 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 488 5-packs
Product Description
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Reason for Recall
Pouch seals may be open, compromising sterility.
Distribution Pattern
Distribution in the US and territories, Japan, and Canada
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0916-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026