Recall Z-0560-2015— Pfm Medical Inc
Class II · Terminated
Class II FDA medical device recall by Pfm Medical Inc, initiated 2014-10-20, terminated 2015-04-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage. Reason: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin..
- Recalling firm
- Pfm Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-20
- Terminated
- 2015-04-23
- Firm location
- Carlsbad, CA, United States
Product description
Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
Reason for recall
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Data sourced from openFDA. This site is unofficial and independent of the FDA.