Level 1 Normothermic I.V. Fluid Administration Set REF D-60HL
FDA Recall Z-0250-2007 · Posted 2006-12-06
Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2006-11-07
Date Terminated2009-11-30
Product Quantity1480 units
Reason for Recall
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.
Firm Action
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.
Root Cause
Equipment maintenance
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.