BEUDAMED
    FDA Recall Terminated

    McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121

    Recall: Z-2473-2021 · Initiated August 11, 2021

    Recall

    Recall Number
    Z-2473-2021
    Event Number
    88561
    Firm
    Cypress Medical Products LLC
    FEI Number
    1451040
    Product Code
    GDY
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    August 11, 2021
    Terminated
    July 7, 2023
    Address
    9954 Mayland Dr, Richmond, VA, 23233-1464

    Description

    McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121

    Reason

    Manufacturer issued a recall due to an EO indicator color. The indicator should change from red to blue signifying sterilization. However, on one case of product, the indicators did not change

    Action

    Cypress Medical Products, LLC is the initial importer for McKesson Medical-Surgical, Inc. Cypress is assisting the distributor (MMS) via Urgent Medical Device Recall letter dated 8/11/21. Letter states reason for recall, health risk and action to take: 1. Cease use of the impacted lot number in your possession. Affected 2. Please contact Cypress Customer Service at [email protected] and return the impacted product to the address listed below: Cypress Medical Products, LLC Attn: Quality Assurance 20951 Walter Strawn Drive Elwood, IL 60421 3. Complete and return the attached Medical Device Recall Response Form to [email protected]. 4. Forward this notification along with the response form the end user

    Distribution

    VA

    Quantity

    1 case (40 packs/cs)