Device product

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support

Z-0916-2022

March 08, 2022

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 89753
Status: Ongoing
Classification: Class II
Quantity: 488 5-packs
Official record key: device-enforcement:Z-0916-2022

Official wording

Reason: Pouch seals may be open, compromising sterility.

Code information: 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

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