Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage

FDA device recall Z-0560-2015 · 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

GCB

Quantity affected

480 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