Z-0568-2015 Class II Terminated
FDA device recall Z-0568-2015 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: 370 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
- 370 units
Product Description
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.
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. 1210-028