Z-0099-2014Class II

Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male...

Name: Z-0099-2014 Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male...
Creator: Baxter Healthcare Corp.
Published: 2013-09-04
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-09-04 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corp. began a recall of Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter... on 2013-09-04. FDA classified it as Class II and gives the reason as "The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination". 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-0099-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-04
Posted: 2013-10-29
Terminated: 2017-04-19
Recalling firm: Baxter Healthcare Corporation
Product: Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015. For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site, which can be connected to standard male Luer adapters for continuous or intermittent fluid administration or the withdrawal of fluids.
Product code: FPA Set, Administration, Intravascular
Reason for recall: The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Baxter sent an Urgent Product Recall letter dated September 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by Customer/User: 1. Locate and remove all affected product from your facility. If you distribute these products to other facilities or departments within your institution, please forward a copy of this communication to ensure that they locate and remove affected product from potential use. The product code and lot number can be found on the shipping carton label and individual product package. 2. Acknowledge your receipt of this recall notification by completing the attached Customer Reply Form (Attachment 1) and return it to Baxter by either faxing it to 224-270-5457 or scanning and emailing it to [email protected]. Returning the Customer Reply Form promptly will prevent you from receiving repeat notifications. 3. The affected product should be returned for credit by contacting Baxter Healthcare Center for Service. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling.Please have the product code and lot number(s) available.
Quantity in commerce: 3,200 units
Distribution: US Distribution including the states of OK, GA, CA, MN, TX and HI.
Product codes and lots: UR13C11089, UR13D16060

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0099-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0099-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-29

Product code FPA

K112893Class IIClearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension SetsBaxter Healthcare Corporation / cleared 2011-10-18

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)