Recall Z-0568-2015
Pfm Medical Inc · initiated October 20, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot No. 1210-028
Reason for recall
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-0568-2015
- Initiated
- October 20, 2014
- Posted by FDA
- December 12, 2014
- Terminated
- April 23, 2015
- Product code
- FJS – Catheter, Peritoneal, Long-Term Indwelling
- 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.
- Recalling firm
- Pfm Medical Inc, Carlsbad, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0560-2015 Class II | Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term…PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for… | 10/20/2014Terminated |
| Z-0561-2015 Class II | ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001…PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for… | 10/20/2014Terminated |
| Z-0562-2015 Class II | ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit…PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for… | 10/20/2014Terminated |
| Z-0563-2015 Class II | Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These…PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for… | 10/20/2014Terminated |
| Z-0564-2015 Class II | 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter…PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for… | 10/20/2014Terminated |
| Z-0565-2015 Class II | ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT…PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for… | 10/20/2014Terminated |
| Z-0566-2015 Class II | Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short…PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for… | 10/20/2014Terminated |
| Z-0567-2015 Class II | Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal…PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for… | 10/20/2014Terminated |