FDAFDA · Food and drugs·Recall number Z-2263-2018
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
Published June 27, 2018 · Recall initiated: April 13, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- TriMed Inc.
- Distributor
- U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden
- Lot
- 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, 009N, 00AL, R904, 00A1, 00PN, 050513, 10505-13, 183501, 83501, 264-05, 004L,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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