FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Level 1 Normothermic I.V. Fluid Administration Set REF DI-60HL (Foreign Distribution Only)
- Recall number
- Z-0251-2007
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Level 1 Normothermic I.V. Fluid Administration Set REF DI-60HL (Foreign Distribution Only)
- Status
- Terminated
- Initiated
- 2006-11-07
- Posted
- 2006-12-06
- Terminated
- 2009-11-30
- 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 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.
- 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.
- Lot, serial or model codes
- Lot number: 725769, 1011870, 1019492, 1011871, 1027190, 1028662, 1037117, 1037809, 1049619, 1058925, 1060998, 1064376, 1067796, 1067797, 1074088, 1074089
- 510(k) numbers
- ["BK860023"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1221261
- Firm city
- Rockland
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28