BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0562-2015 · Initiated October 20, 2014

    Recall

    Recall Number
    Z-0562-2015
    Event Number
    69666
    Firm
    Pfm Medical Inc
    FEI Number
    3013666218
    Product Code
    DWM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 20, 2014
    Posted
    December 12, 2014
    Terminated
    April 23, 2015
    Address
    1815 Aston Ave, Ste 106, Carlsbad, CA, 92008-7340

    Description

    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.

    Reason

    PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

    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 [email protected]. Customers with any questions are instructed to contact Jessica Greene at (760) 758-8749.

    Distribution

    Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.

    Quantity

    1470 units