FDAClass IIDecember 17, 2014

ASEPT Peritoneal Drainage System recall: Endotoxin

ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter…

Why was ASEPT Peritoneal Drainage System recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot No. 1211-002, 1210-016

Product
ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter…
Recalling firm
Pfm Medical Inc
Quantity
83 units
Distribution
Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Recall date
December 17, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls