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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description 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.
Recall Number Z-1972-2012
Classification Class II
Code Info a) 510(k): K060537 b) Medical device listing number: D071942 All enFlow Warmer Straps in the field present a potential for tissue injury. Sold separately as Product #: 980304 and 980304EU Included as an accessory in following enFlow products: Military Domestic 91000153 980100 91000154 980100EU 91000156 980105VS 91000103
Product Distributed Qty 11803 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.

Event Detail

Event Id 62441
Product Type Devices
Status Ongoing
Recalling Firm Vital Signs Devices, a GE Healthcare Company
City Totowa
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-02-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.