Z-1420-2023Class II

ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe

Name: Z-1420-2023 ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
Creator: Baxter Healthcare Corporation
Published: 2023-03-20
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-03-20 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe on 2023-03-20. FDA classified it as Class II and gives the reason as "ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1420-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-20
Posted: 2023-04-20
Recalling firm: Baxter Healthcare Corporation
Product: ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
Product code: KYX Dispenser, Liquid Medication
Reason for recall: ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.
FDA root cause: Under Investigation by firm
Action: Baxter issued an Urgent Medical Device Recall notice to its consignees on 03/20/2023 by USPS. The notice explained the issue and the hazard and requested the following actions be taken: Immediately locate, isolate, and cease all use of the affected product. The product code and lot number can be found on the product carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001, 7:00 am and 6:00 pm Central Time, Monday - Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling. 3. If you received this communication directly from Baxter, please acknowledge receipt by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. 4. If you purchased this product from a distributor, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user level recall of the affected product that you distributed to customers and check the associated box on the customer portal. For general questions regarding this communication, contact Baxter s Center for Service at 888-229-0001, between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
Quantity in commerce: 91,100 units
Distribution: US
Product codes and lots: Lot Number B301S356P

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1420-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1420-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-20

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)