Z-1227-2015Class II

Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100...

Name: Z-1227-2015 Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100...
Creator: Baxter Corporation Englewood
Published: 2014-12-29
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2014-12-29 / Terminated / root cause: labeling and UDI

FDA source

Baxter Corporation Englewood began a recall of Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100... on 2014-12-29. FDA classified it as Class II and gives the reason as "Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1227-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-29
Posted: 2015-02-27
Terminated: 2016-08-08
Recalling firm: Baxter Corporation Englewood
Product: Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025, H938693025, H938696025, H93868025, H93868100, H938672025, H938672100, H938675025, H938675100, H938678025, and H938678100.
Product code: KYX Dispenser, Liquid Medication
Reason for recall: Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Baxter sent an Safety Alert letter dated January 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Baxter is requesting that you take the following actions: 1.Complete the enclosed customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to [email protected]. Returning the customer reply form promptly will prevent you from receiving repeat notices. 2. Please forward a copy of this Safety Alert letter to other facilities or departments within your institutions to ensure that those locations are aware of this action. Action to be taken if you are an end-user and purchased product from a distributor or reseller: 1. Please forward a copy of this Safety Alert letter to other facilities or departments within your institutions to ensure that those locations are aware of this action. 2. Follow your supplier's reply process. Please do not return the customer reply form to Baxter. Action to be taken if you are a distributor: If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please notify your customers of this Safety Alert in accordance with your customary procedures. Further information and support For general questions regarding this communication, contact The Center for One Baxter at 800-422-9837, Monday through Friday, between the hours of 8:00 AM and 5:00 PM Central Time.
Quantity in commerce: 1,404,230
Distribution: Nationwide Distribution
Product codes and lots: All DiscPac products are affected within expiry up to October 2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1227-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1227-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-02-27

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)