Recall Z-0563-2015 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Pfm Medical Inc
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.
| Date | Dec 12, 2014 (initiated Oct 20, 2014) |
| Status | Terminated |
| Reason | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. |
| Root cause | Process control |
| Action | PFm Medical sent an Urgent Device Recall Notification letter dated November 3, 2014 to all their customers who purchased the catheters and other medical devices. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the recall acknowledgement/reply form and fax it to (760) 758-1167 or email it to customerservice@pfmmedicalusa.com. Customers with any questions are instructed to contact Jessica Greene at (760) 758-8749. |
| Quantity | 100 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083873 | PICC (CT RATED AND NON-RATED) Pfm Medical, Inc., Mar 19, 2009 |