- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC, (Green) 4.0mm Ref. 19-12000 Lot 122289 - Spectrum II Disposable Suture Hook 45 degree, Right (RED) Ref. C6380 Lot 122592 Orthopedic manual surgical instrument.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 123263, 122504, 122406, 122592, 122482, 123043, 122289, 122518, 122511.
- 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:
- Surgical Instrument Service And Savings, Inc.
- Reason for Recall:
- The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC, (Green) 4.0mm Ref. 19-12000 Lot 122289 - Spectrum II Disposable Suture Hook 45 degree, Right (RED) Ref. C6380 Lot 122592 Orthopedic manual surgical instrument.
Product Codes/Lot Numbers:
123263, 122504, 122406, 122592, 122482, 123043, 122289, 122518, 122511.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1640-2013
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The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
-Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.
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The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.