BEUDAMED
    FDA Recall Terminated

    Kit: Blood Culture. MAI Kit Part Number: 80315D

    Recall: Z-1558-2021 · Initiated April 9, 2021

    Recall

    Recall Number
    Z-1558-2021
    Event Number
    87722
    Firm
    Medical Action Industries, Inc.
    FEI Number
    1030451
    Product Code
    OFM
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    April 9, 2021
    Posted
    May 12, 2021
    Terminated
    October 3, 2023
    Address
    306 25 Heywood Rd, Arden, NC, 28704-9302

    Description

    Kit: Blood Culture. MAI Kit Part Number: 80315D

    Reason

    Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

    Action

    A written notification letter titled, "URGENT: RECALL NOTIFICATION" was sent to all consignees on 04/09/2021 via email. The letter sent to the distributors instructs the consignees to immediately examine all inventory locations and discontinue use of Medical Action trays affected by this recall. The consignees are instructed to discard any inventory they may have on hand in accordance with the distributor's facility s standard procedures. If any of the affected products identified above were further distributed, the distributor is to ensure all end-users are appropriately notified of this product recall and maintain records of effectiveness. An example of an end-user letter that the distributor can use to notify their customers is attached. The distributor is asked to please report number of responses received and quantities destroyed to [email protected]. The consignee is asked to complete the Recall Response Form and return it as soon as possible even if they do not have product inventory. If the facility has identified recalled product in their inventory, they are asked to please complete the attached Destruction of Material Authorization form when the recalled product is destroyed and return to [email protected] to receive credit. The letter also mentions that any adverse events associated with the use of the affected kits should be reported to [email protected]. The letter that was sent to the end users instructs the consignee to immediately examine all inventory locations and discontinue use of Medical Action trays affected by this recall. The consignee is to discard any inventory they may have on hand in accordance with their facility' s standard procedures. The consignee is to complete the Recall Response Form and return it as soon as possible even if the consignee has no current product inventory. If the facility has identified recalled product in their inventory, they are asked to please complete the attached Destruction of Ma

    Distribution

    Distributed US nationwide to OH, OR, FL and CA.

    Quantity

    205 cases (20 kits per case)