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Terminated

Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids.

FDA Recall Z-2380-2010 · Posted 2010-09-03

Recalling FirmVital Signs Inc
Recall StatusTerminated
Product CodeLGZ
Date Initiated2010-07-15
Date Terminated2015-04-27
Product Quantity385,820 domestic - 20,776 international

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.

Firm Action

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

Distribution Pattern

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 Arabia, Singapore, Switzerland, the Netherlands, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060537EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120Enginivity, LLC · 2006-06-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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