—#49294

Product

Level 1 Normothermic I.V. Fluid Administration Set REF D-60HL

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: BK860023
Affected lot / code info: Lot numbers: 1009446, 1035977, 1043174, 1046075, 1048466, 1060983

Why it was recalled

IV Fluid Administration Set may have a blockage of the recirculating warming fluid channel within the disposable administration set, causing an alarm condition of over-temperature during priming.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Smiths Medical ASD notified Direct customers and distributors via letter sent by UPS on or about November 6, 2006 and the days following as necessary until all consignees are notified. Letters to direct customers will be addressed to the Risk Manager. All Smiths Medical affiliates contacted by e-mail and given instructions to send a letter to their customers and to confirm to Smiths Medical that their customers have taken appropriate action by returning the affected product. US Distributors instructed to return the affected product and to provide a customer list. Foreign distributors instructed to return the affected product and given instructions to send a letter to their customers and to confirm to Smiths Medical that their customers have taken appropriate action by returning the affected product.

Recalling firm

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

Distribution

Distribution pattern: Worldwide, including USA, Japan, Canada, Ireland, UK, Finland, Netherlands, Germany, Austria, Portugal, France, Sweden, Australia, New Zealand, Russia, Italy, Singapore, Kuwait, Saudi Arabia, Czech Republic, Dubai, Spain, Norway, Denmark, and East Temor.

Timeline

Recall initiated: 2006-11-07
Posted by FDA: 2006-12-06
Terminated: 2009-11-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49294. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.