🔍 RecallPedia

ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.

Class I - Dangerous
🏥 Medical Devices Recalled: October 20, 2014 Pfm Medical Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot No. 1307-024, 1302-031, 1210-015
  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:

ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.

Product Codes/Lot Numbers:

Lot No. 1307-024, 1302-031, 1210-015

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0561-2015

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Pfm Medical

Class I - Dangerous

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 →