Turbett Surgical Container TS1200 Recalled Due to Potential Weld Failures
Turbett Surgical Container TS1200 units may have weld failures that could breach the sterile barrier, potentially allowing unsterile instruments to be used in medical procedures and risking infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall for weld failures that could compromise sterile barriers and lead to infection. No illnesses or injuries have been reported, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported,' which scores as High.
Plain-English summary
The FDA is recalling 61 Turbett Surgical Container TS1200 units, which are used to enclose medical devices for sterilization by healthcare providers.
The containers may have weld failures that compromise the sterile barrier. When the barrier is breached, the medical instruments inside may become unsterile. Using non-sterile instruments in medical procedures can lead to patient infections and other serious injuries.
The recalled containers were distributed nationwide to healthcare facilities in California, Iowa, Indiana, North Carolina, New Hampshire, New York, Ohio, Louisiana, South Dakota, Texas, Virginia, and Wisconsin. Healthcare providers who have received affected units should stop using them immediately and contact Turbett Surgical, Inc. for return or replacement instructions. Patients treated using instruments sterilized with these containers should contact their healthcare provider.
The recalled product
- Product
- Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
- Manufacturer
- Turbett Surgical, Inc.
- Affected units
- 61
Distribution
Part of a larger recall action
This product is one of 2 recalled by Turbett Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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