Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ASEPT Peritoneal Drainage System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall ASEPT Peritoneal Drainage System see related information
Date Initiated by Firm October 20, 2014
Date Posted December 12, 2014
Recall Status1 Terminated 3 on April 23, 2015
Recall Number Z-0565-2015
Recall Event ID 69666
510(K)Number K083873  
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Product ASEPT Peritoneal Drainage System, Ref No. P09080002

Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.
Code Information Lot No. 1211-002, 1210-016
Recalling Firm/
Manufacturer		 Pfm Medical Inc
1815 Aston Ave Ste 106
Carlsbad CA 92008-7340
For Additional Information Contact
760-758-8749
Manufacturer Reason
for Recall		 PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
FDA Determined
Cause 2		 Process control
Action PFm Medical sent an Urgent Device Recall Notification letter dated November 3, 2014 to all their customers who purchased the catheters and other medical devices. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the recall acknowledgement/reply form and fax it to (760) 758-1167 or email it to customerservice@pfmmedicalusa.com. Customers with any questions are instructed to contact Jessica Greene at (760) 758-8749.
Quantity in Commerce 83 units
Distribution Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LJS and Original Applicant = PFM MEDICAL, INC
-
-