Device product
6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.
Z-0564-2015
Product summary
- Firm
- Pfm Medical Inc
- Event
- Event 69666
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 units
- Official record key
device-enforcement:Z-0564-2015
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. 1301-038
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.