Z-2165-2013Class II

Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890...

Name: Z-2165-2013 Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890...
Creator: Baxa Corporation
Published: 2013-08-22
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2013-08-22 / Terminated / root cause: labeling and UDI

FDA source

Baxa Corporation began a recall of Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for... on 2013-08-22. FDA classified it as Class II and gives the reason as "Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date". 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-2165-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-22
Posted: 2013-09-06
Terminated: 2016-08-19
Recalling firm: Baxter Corporation Englewood
Product: Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: An Urgent Product Recall notification was mailed to one customer via USPS First Class mail on 8/22/13. The one customer affected by this action was instructed to locate and remove the affected product from inventory and to return to Baxter for credit and/or replacement. Any customer returns received will be discarded per the Corporate Hold.
Quantity in commerce: 34 cases
Distribution: Distributed to One Customer in NC.
Product codes and lots: Lot or Serial No. 785518

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2165-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2165-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-06

Product code LHI

K900585Class IITubing Sets for Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. / cleared 1990-04-18

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