Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot No. 1302-014
  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:
Pfm Medical Inc
Reason for Recall:
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.

Product Codes/Lot Numbers:

Lot No. 1302-014

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0563-2015

Related Recalls

PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

Oct 20, 2014 Surgical Instruments Nationwide View Details →

PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

Oct 20, 2014 Surgical Instruments Nationwide View Details →