—#110397

Product

Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments

FDA product code: LGZ — Warmer, Thermal, Infusion Fluid
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K911383
Affected lot / code info: All serial numbers

Why it was recalled

HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable

Root cause (FDA determination)

Device Design

Action the firm took

Smiths Medical sent an Urgent Medical Device Correction -Field Safety Notice letter dated June 21, 2012 via U.S. Mail to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter included an Urgent Medical Device Field Safety Notice Acknowledgement Form ("Confirmation Form") that customers were instructed to complete and return to Smiths Medical for carrying out the correction and affectivity tracking purposes. The letter stated that a Smiths Medical Representative will visit the affected sites to correct the units with a shelf upgrade kit, which includes instructions and all the parts necessary to make the correction to their affected devices. Customers were provided with a form to record the serial numbers of the devices corrected so that this can be returned to Smiths Medical. For questions regarding this information call Smiths Medical Quality Department at 1-781-763-9335. .

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 160 Weymouth St, Rockland, Massachusetts 02370-1136

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2012-06-27
Posted by FDA: 2012-07-09
Terminated: 2014-02-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110397. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.