Z-0948-2022Class II

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package

Name: Z-0948-2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package
Creator: Baxter Healthcare Corporation
Published: 2022-02-25
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-02-25 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corporation began a recall of Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package on 2022-02-25. FDA classified it as Class II and gives the reason as "Product is mislabeled as self-righting Luer slip tip caps, yellow". 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-0948-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-25
Posted: 2022-04-15
Terminated: 2026-03-02
Recalling firm: Baxter Healthcare Corporation
Product: Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
Product code: KYX Dispenser, Liquid Medication
Reason for recall: Product is mislabeled as self-righting Luer slip tip caps, yellow.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: The recalling firm issued letters dated 2/25/2022 via first class mail to the U.S. consignees. The letter explained the reason for recall, described the affected product, the hazard involved, and the actions to be taken by the customer. Those actions included to immediately check their inventory and segregate the affected product, which had a notation that if there are Luer lock tip caps co-mingled with Luer slip tip caps in the same DISCPAC container, please discard the DISCPAC container and that tip caps that are not co-mingled can continue to be used safely following good pharmacy practices. If the consignee received the letter directly from Baxter, they are to acknowledge receipt by responding on the customer portal. If the product was purchased from a distributor, they only need to respond to the distributor or wholesaler according to their instructions. If the product was further distributed to other facilities or departments within their institution, they were instructed to forward a copy of the letter to them. If the customer is a dealer, wholesaler, distributor/reseller, or original equipment manufacturer that distributed the affected product to other facilities, they are to distribute the notification to them. A Reply Form Instruction Sheet was enclosed which outlined the details of the affected product and Baxter Field Action Portal Acknowledgement Instructions. Notification of OUS consignees began 2/25/2022 via mail, email, or FAX.
Quantity in commerce: 5,500 DISCPACs (100/DISCPAC).
Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, GA, IL, IN, MO, PA, TX, and VA. The countries of Canada, Austria, Germany, Netherlands, Qatar, Saudi Arabia, and Spain.
Product codes and lots: Lot numbers 60268365, 60268609, 60268610, exp. date 10/31/2023; UDI 0085412478852.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0948-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0948-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-27	2022-04-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)