Z-1037-2023 Class II Ongoing
FDA device recall Z-1037-2023 was initiated by Turbett Surgical, Inc. on December 5, 2022 and is designated Class II. Reason for recall: Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries. The recall status is ongoing. Affected quantity: 61 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2023
- Initiation Date
- December 5, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 units
Product Description
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Reason for Recall
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
Distribution Pattern
US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.
Code Information
GTIN: 00859464007281 Lot Number: All Lot Numbers Serial Number: All Serial Numbers