Boston Scientific Corporation Recall 89753
Description: ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Boston Scientific Corporation Recall 89753 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0916-2022 |
Event ID | 89753 |
Event Description | ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support |
Product Type | Devices |
Distribution | Distribution in the US and territories, Japan, and Canada |
Quantity | 488 5-packs |
Recall Reason | Pouch seals may be open, compromising sterility. |
Device Classification | 20220420 |
Device 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 |
Center Classification Date | 20220412 |
Recall Initiation Date | 20220308 |
Recalling Firm | Boston Scientific Corporation |
Initial Notification | Letter |
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