Z-0561-2015 Class II Terminated
FDA device recall Z-0561-2015 was initiated by Pfm Medical Inc on October 20, 2014 and is designated Class II. Reason for recall: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. The recall status is terminated (terminated April 23, 2015). Affected quantity: 120 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2014
- Initiation Date
- October 20, 2014
- Termination Date
- April 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 units
Product 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.
Reason for Recall
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Code Information
Lot No. 1307-024, 1302-031, 1210-015