BEUDAMED
    FDA Recall Terminated

    AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.

    Recall: Z-0435-2016 · Initiated September 3, 2015

    Recall

    Recall Number
    Z-0435-2016
    Event Number
    72276
    Firm
    Summit Medical, Inc.
    FEI Number
    3008719017
    Product Code
    LRD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 3, 2015
    Terminated
    May 2, 2016
    Address
    815 Northwest Pkwy, Ste 100, Eagan, MN, 55121-1658

    Description

    AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.

    Reason

    Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog # RH-7413-10, Lot # 160889 & 161354 because the product does not have the split in the packing.

    Action

    Consignees were sent a Summit Medical "Medical Device Recall" letter, dated September 2, 2015. The letter described the problem and the product involved in the recall. It also advised consignees to immediately examine their inventory, quarantine the product, and to complete the attached response form, as well as follow the instructions provided regarding the affected product. For questions, contact Nicole Dove at 651-789-3921 or [email protected].

    Distribution

    Distributed to CA.

    Quantity

    9 boxes (10 /box)