Terminated

Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156 The device is a medical point-of-care device designed to warm blood and IV fluids.

FDA Recall Z-2008-2009 · Posted 2009-09-04

Recalling FirmEnginivity LLC

Recall StatusTerminated

Product CodeLGZ

Date Initiated2009-03-23

Date Terminated2012-05-02

Product Quantity3052 units

Reason for Recall

1. Fluid contamination of the electronic circuitry can cause short circuits resulting in permanent fuse failure or localized circuit board overheating with possible smoldering and discoloration. 2. Electromagnetic (EMI) Interference associated with the Warmer may produce artifact in ECG, EEG, or EMG records (cardiac or neuro monitoring).

Firm Action

Vital Signs, Inc. issued Product Safety Notification on March 23, 2009 informing users of potential EMI and fluid ingress issues. All warmers in the field will be replaced beginning in May 2009.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- USA, Philippines, Saudi Arabia, India, Israel, Australia, Mexico, Germany, Republic of Singapore, China, Guatemala, Switzerland, Dubai United Arab Emirates, New Zealand, Malaysia, India, Ecuador, & United Kingdom.

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.