Device product
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. 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.
Z-0563-2015
Product summary
- Firm
- Pfm Medical Inc
- Event
- Event 69666
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 units
- Official record key
device-enforcement:Z-0563-2015
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. 1302-014
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.