Recall Z-1899-2011 ยท KSD Device, Heat-Sealing
Haemonetics Corporation
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.
| Date | Apr 6, 2011 (initiated Jan 31, 2011) |
| Status | Terminated |
| Reason | Battery pack may have exposed wire becoming hot |
| Root cause | Equipment maintenance |
| 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 list |
| Quantity | 50,031 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.