Level 1 Normothermic I.V. Fluid Administration Set REF D-60HL
This recall has been terminated (originally issued December 6, 2006).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- November 7, 2006
- Posted
- December 6, 2006
- Terminated
- November 30, 2009
- Recall Number
- Z-0250-2007
- Quantity
- 1480 units
- Firm Location
- Rockland, MA
- Official Source
- View on FDA website ↗
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.
Distribution
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.
Lot / Code Info
Lot numbers: 1009446, 1035977, 1043174, 1046075, 1048466, 1060983
Root Cause
Equipment maintenance
Action Taken
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.