LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of variou
FDA device recall Z-1919-2015 · posted 2015-06-27 · Terminated
Recall details
- Recalling firm
- LifeHealth, LLC
- Reason for recall
- The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.
- Action taken
- Consignees were sent via e-mail a LifeHealth LLC " Urgent" letter dated April, 29th, 2015. The letter described the Purpose of this letter, Reason for the Voluntary Recall, Risk to Health, and Actions to be taken by the Customer. Advised consignees to immediately stop using the recalled product and return it to LifeHealth. Requested consignees to complete and return the Acknowledgement and Receipt Form.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 7
- Distribution
- Worldwide distribution. US in the state of MI; INDONESIA, UNITED ARAB EMIRATES, LITHUANIA, POLAND, and PERU.
- Date initiated
- 2015-04-29
- Date posted
- 2015-06-27
- Date terminated
- 2015-10-20
- Location
- Roseville, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IRMA BLOOD ANALYSIS SYSTEM (K945240) | Diametrics Medical, Inc. | 1995-01-05 |