🔍 RecallPedia

DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

Class I - Dangerous
🏥 Medical Devices Recalled: April 12, 2021 DJ Orthopedics de Mexico S.A. de C.V. Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers:2021-01-05, 2021-01-07, 2021-01-20, 2021-02-05, 2021-03-09, 2021-03-10, 2021-03-13, 2021-03-16, 2021-03-17, 2021-03-18
  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:
DJ Orthopedics de Mexico S.A. de C.V.
Reason for Recall:
failed rivet at the chafe tab of arm sling.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

Product Codes/Lot Numbers:

Lot Numbers:2021-01-05, 2021-01-07, 2021-01-20, 2021-02-05, 2021-03-09, 2021-03-10, 2021-03-13, 2021-03-16, 2021-03-17, 2021-03-18

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1512-2021

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