CLASS II ONGOING Device recall · Reported 26 Apr 2023 · FDA Enforcement Report

ExactaMed Oral Dispenser - Clear Pharmacy Pack recalled

Baxter Healthcare is recalling ExactaMed Oral Dispenser - Clear Pharmacy Pack. The recall was initiated on 20 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number B301S356P

Quantity recalled91,100 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-1420-2023
FDA event ID: 91888
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 20 Mar 2023
FDA classified: 20 Apr 2023
Reported: 26 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Syringes & Needles

Timeline

20 Mar 2023	Recall initiated by company
20 Apr 2023	Classified by FDA	+31 days
26 Apr 2023	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

ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.

Product as listed by the FDA

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

Where it was distributed

Questions about this recall

Why was it recalled?

ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.

Which lots are affected?

Lot Number B301S356P

Where was it sold?

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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