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Boston Scientific Corporation Recall 89753

Description: ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy

Boston Scientific Corporation Recall 89753 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0915-2022
Event ID89753
Event DescriptionROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Product TypeDevices
DistributionDistribution in the US and territories, Japan, and Canada
Quantity433 5-packs
Recall ReasonPouch seals may be open, compromising sterility.
Device Classification20220420
Device Code InfoROTAWIRE 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 Date20220412
Recall Initiation Date20220308
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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