Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood
FDA device recall Z-2380-2010 · posted 2010-09-03 · Terminated
Recall details
- Recalling firm
- Vital Signs Inc
- Reason for recall
- The enFlow Disposable IV Fluid/Blood Warmer Cartridge's male luer-lock fitting may be oversized and may not fit properly with standard female luer fittings.
- Action taken
- GE Healthcare issued an "Urgent Medical Device Correction" letter, dated July 15, 2010, to consignees, identifying the reason for the recall and the affected lots. Customers were instructed to discontinue use of and quarantine the affected devices, and contact Vital Signs Inc. Customer Service to arrange for return and replacement of the affected devices. Consignees were instructed to complete and return the Confirmation Form. Consignees can contact Vital Signs Inc. Customer Service at 1-973-956-5300 .
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- LGZ
- Quantity affected
- 385,820 domestic - 20,776 international
- Distribution
- Worldwide Distribution; USA (all states), and to the countries of Australia, Ecuador, Finland, India, Israel, Latvia, Lebanon, Malaysia, Mexico, Morocco, New Zealand, Panama, Philippines, Qatar, Saudi
- Date initiated
- 2010-07-15
- Date posted
- 2010-09-03
- Date terminated
- 2015-04-27
- Location
- Totowa, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120 (K060537) | Enginivity, LLC | 2006-06-08 |