Class 2 Device Recall enFlow IV Fluid Warmer

• Date Initiated by Firm: February 20, 2012
• Date Posted: July 09, 2012
• Recall Status: Terminated on August 19, 2013
• Recall Number: Z-1972-2012
• Recall Event ID: 62441
• 510(K)Number: K060537
• Product Classification: Warmer, thermal, infusion fluid - Product Code LGZ
• Product: 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.
• Code Information: 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
• FEI Number: 2242551
• Recalling Firm/ Manufacturer: Vital Signs Devices, a GE Healthcare Company; 20 Campus Rd; Totowa NJ 07512-1210
• For Additional Information Contact: Ms. Gwen Anne Braeger; 262-548-2608
• Manufacturer 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.
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 11803 cases
• Distribution: Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LGZ