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U.S. Department of Health and Human Services

Class 2 Device Recall Haemonetics 2380 MINI HandHeld Tube Sealer Power Source

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 Class 2 Device Recall Haemonetics 2380 MINI HandHeld Tube Sealer Power Sourcesee related information
Date Initiated by FirmJanuary 31, 2011
Date PostedApril 06, 2011
Recall Status1 Terminated 3 on March 06, 2012
Recall NumberZ-1899-2011
Recall Event ID 57855
Product Classification Device, Heat-Sealing - Product Code KSD
Product2380 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.
Code Information All serial numbers
FEI Number 1219343
Recalling Firm/
Manufacturer		 Haemonetics Corporation
400 Wood Rd
Braintree MA 02184-2412
For Additional Information Contact
781-848-7100
Manufacturer Reason
for Recall		Battery pack may have exposed wire becoming hot
FDA Determined
Cause 2		Equipment maintenance
ActionThe 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.
Quantity in Commerce50,031 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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