TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemoneti
FDA device recall Z-1738-2011 · posted 2011-03-21 · Terminated
Recall details
- Recalling firm
- Haemoscope Division of Haemonetics Corp
- Reason for recall
- Haemonetics has received a report of smoke from the unit with a power supply failure.
- Action taken
- Haemoscope sent letters to all of their U.S. accounts on January 24, 2011, via certified mail. The letters listed guidelines regarding proper use of the TEG 5000 System Power Supply to eliminate any potential risks such as electrical shorting or power supply damage. The information, which was printed in the letter, will also be available in an updated TEG User Manual soon to be released. A Caution label with installation instructions was included with the letter, to be applied to the back of the TEG unit. The accounts were requested to complete the enclosed acknowledgement form and fax it back to Haemoscope at 847-588-0455. Any questions were directed to 1-800-438-2834.
- Root cause
- Other
- Status
- Terminated
- Product code
- JPA
- Quantity affected
- 1,155 units
- Distribution
- Nationwide Distribution including CA, FL, MD, PA, OH, SC, TN, TX, and VA
- Date initiated
- 2011-01-28
- Date posted
- 2011-03-21
- Date terminated
- 2012-03-12
- Location
- Niles, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES (K002177) | Haemoscope Corp. | 2000-09-14 |