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.
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: 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.
- Affected units
- 6
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
Same manufacturer · Turbett Surgical, Inc.
See all →- HighTurbett Surgical Container TS1200 Recalled Due to Potential Weld Failures
FDA (Devices) · 2023-02-08
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