BEUDAMED
    FDA Recall Terminated

    2380 MINI Hand-Held Tube Sealer Power Source (including a 23802000 Battery Pack) The Model 2380 Power Source is an instrument that generates RF power for making seals on tubing made of RF reactive thermoplastic materials typically used in blood banks, blood processing facilities and transfusion centers.

    Recall: Z-1899-2011 · Initiated January 31, 2011

    Recall

    Recall Number
    Z-1899-2011
    Event Number
    57855
    Firm
    Haemonetics Corporation
    FEI Number
    1219343
    Product Code
    KSD
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    January 31, 2011
    Posted
    April 6, 2011
    Terminated
    March 6, 2012
    Address
    400 Wood Rd, Braintree, MA, 02184-2412

    Description

    2380 MINI Hand-Held Tube Sealer Power Source (including a 23802000 Battery Pack) The Model 2380 Power Source is an instrument that generates RF power for making seals on tubing made of RF reactive thermoplastic materials typically used in blood banks, blood processing facilities and transfusion centers.

    Reason

    Battery pack may have exposed wire becoming hot

    Action

    The firm, Haemonetics, issued a "Field Notification: 2380 Sealer battery pack" letter dated January 28, 2011 to its customers. An international English version of this letter (CL101020-IE) has been released to foreign Distribution countries. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Record the manufacturing date of battery, equipment model, serial number, and photo of the affected battery. 2) Report the defect through the Haemonetics PIR system by emailing: [email protected] with all of the information listed including the appropriate contact information for their company. 3) Recycle or dispose of the nickel-cadmium (NiCad) battery pack in accordance with the local, state, federal, or country specific regulations. Under no circumstances should the battery pack be incinerated as this can cause explosion and personal injury. The operation manual will be updated to provide additional information about the proper installation and removal of the battery. This updated manual will be distributed with new devices upon release. Should you have any questions or concerns regarding this matter, please contact the firm at [email protected].

    Distribution

    Worldwide distribution: USA and countries including: Australia, Austria, AEU, Belgium, Bangladesh, Canada, China, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, New Zealand, Pakistan, Philippines, Singapore, Sri Lanka, Taiwan and Turkey.

    Quantity

    50,031 units