Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

FDA Recall Z-1972-2012 · Posted 2012-07-09

Recalling FirmVital Signs Devices, a GE Healthcare Company
Recall StatusTerminated
Product CodeLGZ
Date Initiated2012-02-20
Date Terminated2013-08-19
Product Quantity11803 cases

Reason for Recall

The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may have contact with skin for less than 24 hours.

Firm Action

GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included customer instructions and a Customer Response Form to be completed and returned to the firm. Contact Customer Service at 1-800-932-0760 for questions regarding this recall.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

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.

↑