Recall Z-0251-2007 ยท FPA Set, Administration, Intravascular
Smiths Medical ASD, Inc.
Level 1 Normothermic I.V. Fluid Administration Set REF DI-60HL (Foreign Distribution Only)
| Date | Dec 6, 2006 (initiated Nov 7, 2006) |
| Status | Terminated |
| Reason | 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 | Equipment maintenance |
| 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 instruct |
| Quantity | 13,640 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| BK860023 | Not in our 510(k) copy |