Device product
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Z-1037-2023
Product summary
- Event
- Event 91314
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 61 units
- Official record key
device-enforcement:Z-1037-2023
Official wording
Reason: Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
Code information: GTIN: 00859464007281 Lot Number: All Lot Numbers Serial Number: All Serial Numbers
Distribution pattern: US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.
Derived failure modes
-
Unknown
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.