BEUDAMED
    FDA Recall Terminated

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

    Recall: Z-0134-2020 · Initiated July 29, 2019

    Recall

    Recall Number
    Z-0134-2020
    Event Number
    83549
    Firm
    ICU Medical Inc
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 29, 2019
    Terminated
    January 12, 2024
    Address
    600 N Field Dr, Lake Forest, IL, 60045-4835

    Description

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

    Reason

    Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

    Action

    ICU Medical notified customers, via Stericycle, Inc., on about 07/29/2019 via "URGENT: MEDICAL DEVICE CORRECTION" letter. Customers were instructed to check inventory and quarantine any sets that are affected by the recall, return them to ICU Medical, inform potential users within your organization of the recall, and complete and return the provided response form. Please notify customers if affected product was further distributed and request that they contact Stericycle at 1-855-311-5437 (M-F, 8am-5pm ET) to receive a reply form. Customers were also requested to consider the following situations: 1. In applications where the use of a filter is not deemed necessary, consider utilizing an administration set without a filter. 2. In applications where filter use is desired and microbore tubing is not required, consider using filtered macrobore sets in place of microbore sets. 3. In cases where a filtered macrobore set is desired but no alternative macrobore set is available contact ICU Medical because a non-filtered set along with an add on filter or filtered extension set could be considered. 4. In instances where the benefits of a filtered microbore infusion set are greater than the potential risks of a filter leak, the product affected by the recall may be utilized out of medical necessity. In these cases, an individualized assessment of benefits and risks should be undertaken with consideration of the unique characteristics of the patient and the infusion itself. When the benefits exceed the risks and the set is deemed medically necessary, users should periodically monitor the vented filter area for leakage. If leaking is observed, consider changing to a new infusion set as soon as clinically appropriate. Report this event to ICU Medical.

    Distribution

    Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    19,350 units