🔍 RecallPedia

Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)

Class I - Dangerous
🏥 Medical Devices Recalled: February 21, 2022 Freudenberg Medical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: PD02, PD00013142 UDI: 00802526618000
  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:
Freudenberg Medical, Llc
Reason for Recall:
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)

Product Codes/Lot Numbers:

Lot Numbers: PD02, PD00013142 UDI: 00802526618000

Distribution:

Distributed in: US, GA, OH

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1017-2022

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