TriMed Nitinol Staples Recalled Due to Missing Sterilization Audit Records
TriMed Inc. is recalling 323 Nitinol staples because evidence of required quarterly sterilization dose audits could not be found, posing a potential infection risk.
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: The recall involves a risk of patient infection from potentially non-sterile medical devices, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
TriMed Inc. is recalling 323 units of Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, including models ES-18x14, ES-20x20, and ES-25x22. The recall was initiated after a retrospective review of sterilization records revealed that evidence of quarterly dose audits and verification, required for regulatory compliance, could not be located.
Although sterilization records indicate that all lots of staples were irradiated to at least the defined dose, the missing audit documentation creates a risk that the devices may not have been properly sterilized. This issue could potentially result in patient infection if the staples were used in a non-sterile state.
The affected products were distributed in the United States to Illinois, Utah, Pennsylvania, New Jersey, Washington, Texas, Nevada, California, North Carolina, Mississippi, Kansas, Missouri, Minnesota, and Florida, as well as in Australia and Sweden. Healthcare providers and facilities should stop using the affected lots and contact TriMed Inc. for further instructions.
The recalled product
- Product
- Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
- Manufacturer
- TriMed Inc.
- Affected units
- 323
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #: a) R900
- 009J
- 050511
- 00AG
- 0095
- 183601
- 10505-11
- 193601
- b) R903
- 26404
- 264-04
- 03NK
- 050512
- 10505-12
- 24604
- 11811
- 181102
- 181103
- 188803
- c) 26405
Distribution
Part of a larger recall action
This product is one of 4 recalled by TriMed 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.
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