Device product
Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
Z-0560-2015
Product summary
- Firm
- Pfm Medical Inc
- Event
- Event 69666
- Status
- Terminated
- Classification
- Class II
- Quantity
- 480 units
- Official record key
device-enforcement:Z-0560-2015
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. 1401-040
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.