Z-1132-2022 Class II Ongoing

Recalled by Stradis Healthcare — Waukegan, IL

Recall Details

Product Type
Devices
Report Date
June 1, 2022
Initiation Date
April 22, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7340 units

Product Description

Surgical Suture Kit

Reason for Recall

There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.

Distribution Pattern

US Distribution to NC.

Code Information

Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717