FDAFDA · Food and drugs·Recall number Z-0915-2022
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Published April 20, 2022 · Recall initiated: March 8, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Pouch seals may be open, compromising sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Distribution in the US and territories, Japan, and Canada
- Lot
- ROTAWIRE Drive Floppy, 5 pack, UPN: H74939462005 Individual units within 5-pack are labeled as Single, UPN: H74939462001 Batch numbers: 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019 27756205, 27756933, and 27756935 GTIN: 08714729996255
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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