BEUDAMED
    FDA Recall Terminated

    CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"

    Recall: Z-0099-2015 · Initiated October 18, 2013

    Recall

    Recall Number
    Z-0099-2015
    Event Number
    66541
    Firm
    Intra Pump Infusion Systems
    FEI Number
    3004839315
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 18, 2013
    Posted
    October 21, 2014
    Terminated
    February 1, 2016
    Address
    920 Minters Chapel Rd, Ste 200, Grapevine, TX, 76051-1302

    Description

    CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"

    Reason

    Product has the potential to have a clear debris on the tip of the needle.

    Action

    Cane S.p.A. Medical Technology sent an Urgent: Correction and Removal Action Required letter dated October 21, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: a. Stop using the 19G x 11/2" 1.10 x 40mm steelneedle included in the CRONO Syringe blister pack. B. Safely discard the 19G x 11/2" 1.10 x 40mm steel needle into a Sharps container. c. Use a TRANSFER DEVICE (e.g.,Needleless adapter with female-to-female luer connector) or alternative device to transfer medications into the CRONO syringe. d.For intravenous infusions,we are recommending that a filter also be used during infusions. e. Complete the required 'Acknowledgment and Receipt Form'and fax back to our Distributor;Intra Pump Infusion Systems at 630-845-2768. Contact Information for our US Distributor: INTRA PUMP INFUSION SYSTEMS " Monday through Friday 8:00am to 5:00pm CST,TollFree:1-866- 211-7867 " Direct:630-845-7867 " Fax:630-845-2768 www.lntrapump.com

    Distribution

    Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.

    Quantity

    25,440 pieces