Z-1179-2016Class II

Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007

Name: Z-1179-2016 Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
Creator: CareFusion 303, Inc.
Published: 2016-02-15
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2016-02-15 / Terminated

FDA source

CareFusion 303, Inc. began a recall of Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007 on 2016-02-15. FDA classified it as Class II and gives the reason as "CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1179-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-15
Posted: 2016-03-17
Terminated: 2016-10-24
Recalling firm: CareFusion 303, Inc
Product: Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
Product code: FPA Set, Administration, Intravascular
Reason for recall: CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.
FDA root cause: Other
Action: A customer notification letter dated 2/15/16 will be sent to customers to inform them that CareFusion is recalling the Alaris VersaSafe Infusion set number 2122-0007, Lot number 13085603. The letter informs the customers that Separation or leakage at the VersaSafe split septum port and tubing may lead to leakage of the administration set. The separation and leakage may occur during infusion. The letter informs customers of the potential risk and actions to be taken. Customers with recall related equations are instructed to contact CareFusion Support Center at (888) 562-6018, 7am-4pm PST. Customers with adverse event reports are instructed to contact Customer Advocacy at (888)812-3266, [email protected], 24 hrs/day, 7 days/wk. Customers are instructed to complete and return the enclosed mandatory customer response card to acknowledge the receipt of the customer communication.
Quantity in commerce: 5,760 units
Distribution: Michigan
Product codes and lots: Lot No. 13085603

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1179-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1179-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-17

Product code FPA

K944320Class IIVented/non-Vented Gemini Administration SetImed Corp. / cleared 1995-02-14

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)