Boston Scientific Corporation Recall 89753
Description: ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Boston Scientific Corporation Recall 89753 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0915-2022 |
| Event ID | 89753 |
| Event Description | ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy |
| Product Type | Devices |
| Distribution | Distribution in the US and territories, Japan, and Canada |
| Quantity | 433 5-packs |
| Recall Reason | Pouch seals may be open, compromising sterility. |
| Device Classification | 20220420 |
| Device Code Info | 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 |
| Center Classification Date | 20220412 |
| Recall Initiation Date | 20220308 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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