Recall Z-0562-2015 ยท DWM Apparatus, Suction, Patient Care
Pfm Medical Inc
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
| 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 | 1470 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
| K093307 | ASEPT PLEURAL DRAINAGE SYSTEM Pfm Medical, Inc., Nov 6, 2009 |