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.
This recall has been terminated (originally issued July 9, 2012).
- Recall Initiated
- February 20, 2012
- Posted
- July 9, 2012
- Terminated
- August 19, 2013
- Recall Number
- Z-1972-2012
- Quantity
- 11803 cases
- Firm Location
- Totowa, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / 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
Root Cause
Device Design
Action Taken
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.