Events

Recall of Device Recall Haemonetics 2380 MINI HandHeld Tube Sealer Power Source

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Haemonetics Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57855
  • Event Risk Class
    Class 2
  • Event Number
    Z-1899-2011
  • Event Initiated Date
    2011-01-31
  • Event Date Posted
    2011-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97588
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, Heat-Sealing - Product Code KSD
  • 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: sebra2380@haemonetics.com 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 sebra2380@haemonetics.com.

Device

Device Recall Haemonetics 2380 MINI HandHeld Tube Sealer Power Source
  • Model / Serial
    All serial numbers
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Haemonetics Corporation

Manufacturer

Haemonetics Corporation
  • Manufacturer Address
    Haemonetics Corporation, 400 Wood Rd, Braintree MA 02184-2412
  • Manufacturer Parent Company (2017)
    Haemonetics Corporation
  • Source
    USFDA