🔍 RecallPedia

American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Class I - Dangerous
🏥 Medical Devices Recalled: March 31, 2016 American Surgical Company Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot numbers: 2015/10 AP
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
American Surgical Company
Reason for Recall:
Product packaging defective compromising sterility
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Product Codes/Lot Numbers:

Lot numbers: 2015/10 AP

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1744-2016

Related Recalls

Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A

American Surgical Company

Class I - Dangerous

Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field.

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