Recall Z-0568-2015 ยท FJS Catheter, Peritoneal, Long-Term Indwelling
Pfm Medical Inc
ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.
| 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 | 370 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 |