Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: a) R901, 03UU, 050522, 10505-22, 0344, 0051, 11805, 00AJ, 10505-23, 050523, 180502, 180901, 180503, 18902; b) 03UV, 050523, 10505-23, 00AJ, 0052, 180901, 11809, 180902, 26408, 264-08, 11805, 180502, 118901
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- TriMed Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
Product Codes/Lot Numbers:
Lot #: a) R901, 03UU, 050522, 10505-22, 0344, 0051, 11805, 00AJ, 10505-23, 050523, 180502, 180901, 180503, 18902; b) 03UV, 050523, 10505-23, 00AJ, 0052, 180901, 11809, 180902, 26408, 264-08, 11805, 180502, 118901
Distribution:
Distributed in: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2262-2018
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