Z-1132-2022 Class II Ongoing
FDA device recall Z-1132-2022 was initiated by Stradis Healthcare on April 22, 2022 and is designated Class II. Reason for recall: There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity. The recall status is ongoing. Affected quantity: 7340 units.
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