Z-0871-2015Class II

Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare...

Name: Z-0871-2015 Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare...
Creator: Baxter Corporation Englewood
Published: 2014-12-04
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2014-12-04 / Terminated / root cause: manufacturing process

FDA source

Baxter Corporation Englewood began a recall of Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112... on 2014-12-04. FDA classified it as Class II and gives the reason as "Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation". 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-0871-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-04
Posted: 2014-12-24
Terminated: 2016-11-30
Recalling firm: Baxter Corporation Englewood
Product: Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile
Product code: KYX Dispenser, Liquid Medication
Reason for recall: Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Baxter sent an Urgent Product Recall letter via USPS to all affected customers dated December 8, 2014.The letter identified the product the problem and the action needed to be taken by the customer. Customers are instructed to locate and remove all affected product from their facility, and to contact Baxter Healthcare to arrange for return and credit.Returned products will be destroyed./discarded. If you have questions regarding the content of the communication, please call The Center for One Baxter at (1-800) 422-9837, between the hours of 8:00am and 5:00pm Central time.
Quantity in commerce: 54,000
Distribution: Worldwide Distribution - US Distribution to the states of UT, TX, and IL, and to the countries Austria, Germany, Spain, Switzerland, and Netherlands. No VA/military/govt consignees.
Product codes and lots: Product Code H93869100, Lot 1001380 and Product Code H93866100, Lot 1001365

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0871-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0871-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-24

Product code KYX

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