BEUDAMED
    FDA Recall Terminated

    ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills

    Recall: Z-1284-2019 · Initiated March 22, 2019

    Recall

    Recall Number
    Z-1284-2019
    Event Number
    82535
    Firm
    Cardinal Health
    FEI Number
    3014524790
    Product Code
    LZA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 22, 2019
    Terminated
    August 6, 2021
    Address
    200 LLC 15 Hampshire St, Bldg 5, Mansfield, MA, 02048-1113

    Description

    ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills

    Reason

    Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap

    Action

    Cardinal Health issued recall letter dated March 22, 2019 stating reason for recall, health risk and Action Required: 1. INSPECT inventory.2. SEGREGATE and QUARANTINE all on-hand product. 3. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product youve quarantined or discarded. 4. NOTIFY customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit of any affected product Monday Friday between 8:00am - 5:00pm EST: Hospital800-964-5227 Federal Government800-444-1166 Distributor800-635-6021 All other customers888-444-5440. On 4/17/19 the firm issued the Correction Letter action and provided sticker labels-stating Warning Product contains natural rubber latex which may cause an allergic reaction. Action to take: INSPECT your inventory for the affected product code and lot number (listed on package) .SEGREGATE and QUARANTINE all on-hand product. 3. AFFIX the enclosed warning label on the principal display panel over the current not made with natural latex labeling (if applicable) on affected kits as shown in example 1. 4. ADDITIONAL labels can be obtained by contacting 800-292-9332 or [email protected] for assistance.

    Distribution

    Worldwide Distribution - US Nationwide: Foreign: Bahamas, Canada, Chile, Guam, Israel, Japan

    Quantity

    21082