Z-2548-2017 Class II Terminated

Recalled by Medtronic — North Haven, CT

Recall Details

Product Type
Devices
Report Date
June 21, 2017
Initiation Date
May 3, 2017
Termination Date
July 18, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
478,465 (total for all products)

Product Description

SCHRITTMACHER ANGIO X3; Item Number: 4045255423347

Reason for Recall

Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

Distribution Pattern

Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.

Code Information

228111X