TriMed recalls specific Nitinol elastic staples due to potential patient infection risks from improper sterilization records. Affected lots include ES-18x14, ES-20x20, and ES-25x22 models with certain lot numbers.
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
TriMed is recalling specific Nitinol elastic staples that may not have been properly sterilized, posing a risk of patient infection. This recall is based on missing sterilization records that could indicate improper sterilization processes.
The recall stems from TriMed's finding that sterilization records lacked evidence of required quarterly dose audits. This could mean the staples weren't properly sterilized, increasing the risk of patient infection.
Healthcare professionals using the recalled staples for medical procedures are affected. Patients receiving procedures with these staples face the risk of infection.
Check for the model numbers ES-18x14, ES-20x20, or ES-25x22 on the staple packaging. Affected lots include specific numbers listed in the recall notice.
Identify the model number on the staple packaging to see if it matches ES-18x14, ES-20x20, or ES-25x22.
TriMed found missing sterilization records that could indicate improper sterilization, raising the risk of patient infection.
The recall indicates a potential risk of infection if not properly sterilized; affected lots should not be used.
Check the model and lot numbers to see if they are affected. If so, contact TriMed for guidance.
We’ve drafted a message you can send TriMed to request your refund or repair — edit it as you like.
Subject: Recall Z-2263-2018 — TriMed TriMed Hello, I own a TriMed that is covered by recall Z-2263-2018 from TriMed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
