Z-0435-2014Class II

VersaSafe Extension Set, Model No. 21000M-007

Name: Z-0435-2014 VersaSafe Extension Set, Model No. 21000M-007
Creator: CareFusion 303, Inc.
Published: 2013-11-08
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2013-11-08 / Terminated / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of VersaSafe Extension Set, Model No. 21000M-007 on 2013-11-08. FDA classified it as Class II and gives the reason as "CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0435-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-08
Posted: 2013-12-03
Terminated: 2014-04-17
Recalling firm: CareFusion 303, Inc
Product: VersaSafe Extension Set, Model No. 21000M-007
Product code: FPA Set, Administration, Intravascular
Reason for recall: CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: A customer letter and a distributor letter will be distributed on 11/8/13 to all customers who purchased the VersaSafe Extension Set, Model 21000M-07, Lot Number 13066550. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card.
Quantity in commerce: 3500 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot No. 13066550

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0435-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0435-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-03

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)