FDA Medical Device Recalls (openFDA)
Cardinal Health 303 Inc DBA Alaris Products: Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013
- Recall number
- Z-1078-2007
- Recalling firm
- Cardinal Health 303 Inc DBA Alaris Products
- Product
- Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013
- Status
- Terminated
- Initiated
- 2007-06-05
- Posted
- 2007-08-03
- Terminated
- 2012-02-10
- Reason
- The sterility of the product may be compromised as the packaging used for the sterility barrier was not designed for the sterility process used by the firm.
- Root cause
- Other
- Action
- Recall Notification consists of a phone call and Recall Notification letters to consignees (distributors) as well as direct customers. On June 5, 2007, Cardinal Health began calling customers and distributors to inform them of a recall affecting IV Administration Set, Model C20014, Lot Number 07036013 (Low Sorbing Extension Set). A follow-up Recall Notification Letter was sent on June 11, 2007. The customers and distributors were notified by registered return receipt mail. For direct customers, letters were sent directly to the point of contact at the hospital. For distributors, they were sent multiple copies of the Recall Notification; along with a cover letter outlining their responsibilities to complete the Recall plan and notify their customers as requested.
- Quantity
- 4,248 sets (59 boxes)
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot Number 07036013
- 510(k) numbers
- ["K872764"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3003879246
- Firm city
- San Diego
- Firm state
- CA
- 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