🔍 RecallPedia

SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult

Class I - Dangerous
🏥 Medical Devices Recalled: February 8, 2021 Sharp Medical Products Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Catalogue Number: 100-36-01 Lot Number: 0818-009
  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:
Sharp Medical Products
Reason for Recall:
Non-conformity (holes/punctures or deep creases) in the sterile barrier.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult

Product Codes/Lot Numbers:

Catalogue Number: 100-36-01 Lot Number: 0818-009

Distribution:

Distributed in: AZ, FL, MI, OH, TX, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1366-2021