Z-0109-2014Class II

Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter...

Name: Z-0109-2014 Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter...
Creator: Baxter Healthcare Corp.
Published: 2013-08-30
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-08-30 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corp. began a recall of Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division... on 2013-08-30. FDA classified it as Class II and gives the reason as "Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471". 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-0109-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-30
Posted: 2013-10-30
Terminated: 2017-04-19
Recalling firm: Baxter Healthcare Corporation
Product: Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471
Root cause tag: packaging
FDA root cause: Packaging
Action: The firm, Baxter, sent an "Urgent Product Recall" letter dated September 10, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to locate and remove all affected product from your facility; If you distributed the products to other facilities or departments, forward them a copy of the letter; complete and return the attached Customer Reply Form via fax to 1-224-270-5457 or scan and email to [email protected]; and contact Baxter Healthcare Center for Service at 1-888-229-0001 between hours of 7:00 am and 6:00pm Central Time to return affected product and receiving credit. For additional information contact the Center for One Baxter at 1-800-422-9837, Monday thru Friday during the hours of 8:00am to 5:00pm Central Time.
Quantity in commerce: 49,344 units
Distribution: Nationwide distribution.
Product codes and lots: R13D09024, R13D09107, R13D12101, R13D17068, R13D18066, R13D20070

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0109-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0109-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-29

Product code FPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)