🔍 RecallPedia

LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

Class I - Dangerous
🏥 Medical Devices Recalled: September 11, 2024 Waldemar Link GmbH & Co. KG (Corp. Hq.) Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 04026575215539; Lot Codes: C204156; C219063; C219064; C233033; C233034; C332135
  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:
Waldemar Link GmbH & Co. KG (Corp. Hq.)
Reason for Recall:
Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

Product Codes/Lot Numbers:

UDI-DI: 04026575215539; Lot Codes: C204156; C219063; C219064; C233033; C233034; C332135

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3245-2024

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