Device product

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy

Z-0915-2022

March 08, 2022

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 89753
Status: Ongoing
Classification: Class II
Quantity: 433 5-packs
Official record key: device-enforcement:Z-0915-2022

Official wording

Reason: Pouch seals may be open, compromising sterility.

Code information: 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

Distribution pattern: Distribution in the US and territories, Japan, and Canada

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

seals may be open, compromising sterility