Reported Jul 18, 2012 · Terminated
enFlow IV Fluid Warmer (510k name
Vital Signs Devices, a GE Healthcare Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vital Signs Devices, a GE Healthcare Company · 20 Campus Rd · Totowa, NJ · 07512-1210
Is this the product you have?
enFlow IV Fluid Warmer (510k name
3 of 3 products
| Model / number | Product as published |
|---|---|
100 | EFLOW DISPOSABLE CARTRIDGE |
200 | AND EFLOW AC POWER SUPPLY |
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. |
- Lot codes and dates
- a) 510(k)K060537
- b) Medical device listing numberD071942 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 productsMilitary Domestic 91000153 980100 91000154 980100EU 91000156 980105VS 91000103
- Amount recalled
- 11803 cases
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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