BEUDAMED
    FDA Recall Terminated

    DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

    Recall: Z-2595-2014 · Initiated August 5, 2014

    Recall

    Recall Number
    Z-2595-2014
    Event Number
    69066
    Firm
    Catheter Connections, Inc.
    FEI Number
    3009141010
    Product Code
    LKB
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    August 5, 2014
    Posted
    September 5, 2014
    Terminated
    October 8, 2014
    Address
    615 Arapeen Dr, Ste 302A, Salt Lake City, UT, 84108

    Description

    DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

    Reason

    Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.

    Action

    The firm, Catheter Connections, sent an "Urgent: Medical Device Field Action" letter dated August 5, 2014 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to identify any customers who received this product having lot no. 1406509; make all potential users in your facility are made aware of this notification and the recommended actions; forward the attached URGENT MEDICAL DEVICE CORRECTION LETTER to customers immediately via fax or email; search your inventory and instruct all users to check each cap coming from the specific affected lot; quarantine and discard any defective product; and complete and return the attached URGENT MEDICAL DEVICE FIELD ACTION REPLY FORM via fax to 1-888-862-2693 or email to: [email protected]. Catheter Connections does not require the return of devices having the affected lot number. If you have questions, please contact Catheter Connections at 1-801-906-0820 (M-F, 8:00 am - 5:00 pm MST) and ask for Quality Department.

    Distribution

    US Distribution to states of: CT, GA, MD, and PA. .

    Quantity

    24,910 units