FDA Medical Device Recalls (openFDA)
Sorenson Medical, Inc.: ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, Sorenson Medical, Inc., West Jordan, Utah.
- Recall number
- Z-0186-2007
- Recalling firm
- Sorenson Medical, Inc.
- Product
- ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, Sorenson Medical, Inc., West Jordan, Utah.
- Status
- Terminated
- Initiated
- 2006-10-10
- Posted
- 2006-11-16
- Terminated
- 2011-05-26
- Reason
- Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
- Root cause
- Other
- Action
- Consignees were notified by letter on 10/10-11/2006 and told to immediately discontinue use/quarantine all affected cassettes. .
- Quantity
- 30,697 units
- Distribution
- Worldwide, including USA, Belgium, France, Germany, Italy, Singapore, Venezuela.
- Lot, serial or model codes
- REF 220140, all serial numbers
- 510(k) numbers
- ["K002434","K033325","K052221"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1000117099
- Firm city
- West Jordan
- Firm state
- UT
- 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