BEUDAMED
    FDA Recall Terminated

    Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.

    Recall: Z-0209-2020 · Initiated September 10, 2019

    Recall

    Recall Number
    Z-0209-2020
    Event Number
    83839
    Firm
    Candela Corporation
    FEI Number
    1218402
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 10, 2019
    Posted
    October 24, 2019
    Terminated
    October 20, 2020
    Address
    530 Boston Post Rd, Wayland, MA, 01778-1833

    Description

    Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.

    Reason

    The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules

    Action

    1. Immediately examine your inventory and quarantine the identified lots of the GentleCool Pro Cryogen Canister. 2. Immediately discontinue use and distribution of the identified lots of the GentleCool Pro Cryogen Canister. 3. Please complete and return the enclosed Acknowledgement Form - GentleCool Pro Canister Recall. The completed form must be scanned and emailed to [email protected] within 24 hours. 4. If you may have further distributed this product, please identify those locations and notify them at once of this product recall. Your communication should include a copy of this recall notification letter. 5. Please contact Candela Customer Service at 800-733-8550 ext. 0 to make arrangements for replacement of your affected inventory. 6. Information regarding retrieval of your affected inventory will be forthcoming from Candela Medical. If you have any questions, please do not hesitate to call our Customer Service team at 800-733-8550 ext. 0, M-F 8:30 am 8 pm EST, or reach them via email at [email protected]. An Urgent Medical Device Expanded Recall notification letter dated 12/6/19 was sent to customers. Twenty additional lots have now been identified (listed in bold on the following page), since the initial notification was sent mid-September. Thus, we are updating this notice to make you aware of these additional lots. The reason for this expanded recall is unchanged from the initial communications sent. Actions to Be Taken by the Customer/User: To safely and efficiently implement this recall, we are asking that you please take the following actions: 1. Immediately examine your inventory and quarantine the identified lots of the GentleCool Pro Cryogen Canister. 2. Immediately discontinue use and distribution of the identified lots of the GentleCool Pro Cryogen Canister. 3. Please complete and return the enclosed Acknowledgement Form - GentleCool Pro Canister Recall. The completed form must be sca

    Distribution

    States: NC GA CA MA OH FL IL CO SD NY KS WA MI PA AZ WI TX LA IA MN VA TN SC OR IN WY MD VT ON BC QC NV OUS: Barbados Canada Germany Spain France HR Portugal Ireland Norway Greece NL South Africa Vietnam Hong Kong Japan New Zealand Australia China Korea

    Quantity

    in total 7,560 canisters (3240 additional as of 2/5/20)