Z-0806-2018Class II

Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105

Name: Z-0806-2018 Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Creator: Baxter Healthcare Corporation
Published: 2018-02-06
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2018-02-06 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105 on 2018-02-06. FDA classified it as Class II and gives the reason as "Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL)". 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-0806-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-06
Posted: 2018-03-01
Terminated: 2021-04-02
Recalling firm: Baxter Healthcare Corporation
Product: Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Product code: KYZ Syringe, Irrigating (Non Dental)
Reason for recall: Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Customers were notified via letter on about 02/06/2018. Instructions include to locate and remove affected product in inventory, confirm mislabeled 5 mL oral dispensers (Lot number 1203395) in the individual pouch are not mixed together with 1 mL oral dispensers (Product code H93876101) or other stored product, contact Baxter Healthcare Center to arrange return of affected product, and complete and return the customer reply form if purchased directly from Baxter. Also, customer are instructed to notify customers and conduct a consumer-level recall if the affected product was further distributed. Questions and concerns can be directed to the Public Contact, Center for One Baxter with phone number (Toll Free) 800-422-9837 and 847-948-4770, Monday through Friday 8:00 AM to 5:00 PM CST.
Quantity in commerce: 2,800 units
Distribution: Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.
Product codes and lots: Lot No. 1203395, Expiration Date 11/30/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0806-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0806-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code KYZ

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)