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Boston Scientific Corporation Recall 89753

Description: ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support

Boston Scientific Corporation Recall 89753 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0916-2022
Event ID89753
Event DescriptionROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Product TypeDevices
DistributionDistribution in the US and territories, Japan, and Canada
Quantity488 5-packs
Recall ReasonPouch seals may be open, compromising sterility.
Device Classification20220420
Device Code InfoROTAWIRE 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 Date20220412
Recall Initiation Date20220308
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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