Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ASEPT 2000 ml Drainage Bag Recalled by Pfm Medical Inc Due to PFM Medical is recalling catheters and other medical...

Date: October 20, 2014
Company: Pfm Medical Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Pfm Medical Inc directly.

Affected Products

ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.

Quantity: 370 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Pfm Medical Inc

Pfm Medical Inc has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report