Turbett Surgical Container TS1000 may have weld failures breaching sterile barrier
Turbett Surgical Container TS1000 may have weld failures that breach the sterile barrier, potentially resulting in unsterile instruments being used in medical procedures and risking patient infection or injury.
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 FDA Class II medical device recall addresses a potential hazard (weld failure leading to breach of sterile barrier) that could result in patient infection or serious injury. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Turbett Surgical, Inc. is recalling the Turbett Surgical Container, TS1000, a device used to enclose other medical instruments for sterilization in healthcare settings.
The device may have weld failures that can breach the sterile barrier. If the sterile barrier is breached, medical instruments enclosed in the container may become unsterile.
The use of unsterile instruments during medical procedures poses a risk of infection and serious injury to patients. All lot numbers and serial numbers of the TS1000 are included in this recall.
The affected product was distributed nationwide to healthcare facilities in California, Iowa, Indiana, North Carolina, New Hampshire, New York, Ohio, Louisiana, South Dakota, Texas, Virginia, and Wisconsin.
The recalled product
- Product
- Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
- Manufacturer
- Turbett Surgical, Inc.
- Hazard
- sterile-barrier-breach
- infection-risk
- weld-failure
Distribution
Distributed nationwide across the United States.
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