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 - DangerousWhat Should You Do?
- Check if you have this product: Lot No. 1302-014
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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.govFDA 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.
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.