Recall Z-0564-2015 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Pfm Medical Inc
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
| 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 | 90 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 |