Z-0143-2014Class II

Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices...

Name: Z-0143-2014 Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices...
Creator: Baxter Healthcare Corp.
Published: 2013-09-10
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-09-10 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets on 2013-09-10. FDA classified it as Class II and gives the reason as "The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events". 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-0143-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-10
Posted: 2013-11-06
Terminated: 2015-06-05
Recalling firm: Baxter Healthcare Corporation
Product: Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
Product code: OBK Port, Protector/Cushion
Reason for recall: The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Baxter sent an Urgent Product Recall notification dated September 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to : 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 returning it to Baxter by either faxing it to 1-224-270-5457 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 1-888-229-0001 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. 4.If you are a dealer, wholesaler,or distributor/reseller that distributed any product to other facilities, please forward this communication. Baxter distributed this product to customers between June 19, 2013 and August 20, 2013. The Center for One Baxter is available at 1-800-422-9837, Monday through Friday during the hours of 8:00 am to 5:00 pm Central Time.
Quantity in commerce: 628,992 units
Distribution: Worldwide Distribution - USA (nationwide) and the country of Canada.
Product codes and lots: 10043, 10044

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0143-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0143-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-06

Product code OBK

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)