Turbett Surgical Container TS1500 weld failures breach sterile barrier
The Turbett Surgical Container TS1500 is being recalled because eight units manufactured before June 2019 have exhibited weld failures that breach the sterile barrier during prolonged use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II recall for a medical device with a breach of sterile barrier—a significant risk in surgical equipment. However, no illnesses or injuries have been reported, and the hazard remains theoretical. Per the rubric, absence of reported harm with a risk-of-harm product scores at most 3.
Plain-English summary
The Turbett Surgical Container TS1500 is being recalled due to weld failures that breach the sterile barrier. Eight units manufactured before June 2019 have exhibited these weld failures during prolonged use.
The recall involves 232 units distributed to healthcare facilities in Pennsylvania, California, and New York. The affected units are identified by lot numbers and serial numbers detailed in FDA recall notice Z-1111-2022.
A breach in the sterile barrier of a surgical container poses a risk of contamination. Healthcare facilities should verify their inventory against the list of affected units.
The recalled product
- Product
- Turbett Surgical Container, TS1500
- Manufacturer
- TURBETT SURGICAL, LLC
- Hazard
- weld-failure
- sterile-barrier-breach
- contamination-risk
Distribution
Distributed in 3 states:
- CA
- NY
- PA
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