ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage w
FDA device recall Z-0568-2015 · posted 2014-12-12 · Terminated
Recall details
- Recalling firm
- Pfm Medical Inc
- Reason for recall
- PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FJS
- Quantity affected
- 370 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
- Date initiated
- 2014-10-20
- Date posted
- 2014-12-12
- Date terminated
- 2015-04-23
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VETA PERITONEAL DIALYSIS CATHETER (K113354) | Pfm Medical, Inc. | 2012-03-13 |
| ASEPT PERITONEAL DRAINAGE SYSTEM (K093796) | Pfm Medical, Inc. | 2010-02-26 |