Z-0563-2015 Class II Terminated
FDA device recall Z-0563-2015 was initiated by Pfm Medical Inc on October 20, 2014 and is designated Class II. Reason for recall: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. The recall status is terminated (terminated April 23, 2015). Affected quantity: 100 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2014
- Initiation Date
- October 20, 2014
- Termination Date
- April 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units
Product Description
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.
Reason for Recall
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Code Information
Lot No. 1302-014