CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report

Sterile Exactamed Oral Dispenser, Clear recalled by Baxter Healthcare

Baxter Healthcare is recalling Sterile Exactamed Oral Dispenser, Clear, Individually Packaged, distributed in 8 states. The recall was initiated on 6 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. 1203395, Expiration Date 11/30/2019

Quantity recalled2,800 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0806-2018
FDA event ID: 79090
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 6 Feb 2018
FDA classified: 1 Mar 2018
Reported: 7 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

6 Feb 2018	Recall initiated by company
1 Mar 2018	Classified by FDA	+23 days
7 Mar 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

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

Where it was distributed

Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.

Illinois Massachusetts Maryland Ohio South Dakota Texas Virginia Wisconsin

Questions about this recall

Why was it recalled?

Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).

Which lots are affected?

Lot No. 1203395, Expiration Date 11/30/2019

Where was it sold?

Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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