Device product
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
Z-0562-2015
Product summary
- Firm
- Pfm Medical Inc
- Event
- Event 69666
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1470 units
- Official record key
device-enforcement:Z-0562-2015
Official wording
Reason: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Code information: Lot No. 1307-065, 1301-009
Distribution pattern: Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Derived failure modes
-
Unknown
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.