Z-1078-2007

Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris...

Name: Z-1078-2007 Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris...
Creator: Cardinal Health 303 Inc DBA Alaris Products
Published: 2007-06-05
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2007-06-05 / Terminated / root cause: packaging

FDA source

Cardinal Health 303 Inc DBA Alaris Products began a recall of Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013 on 2007-06-05. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1078-2007
Status: Terminated
Initiated: 2007-06-05
Posted: 2007-08-03
Terminated: 2012-02-10
Recalling firm: CareFusion 303, Inc
Product: Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013
Product code: FRN Pump, Infusion
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 4,248 sets (59 boxes)
Distribution: Nationwide.
Product codes and lots: Lot Number 07036013

Product code FRN

K872764Class IIIvac Nitroglycerin & Lipid Admin. Set Model S75053Y / cleared 1987-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)