CLASS III Device recall · Reported 4 Sep 2019 · FDA Enforcement Report
Exactamed Oral Dispensers, Amber: Pharmacy Pack recalled
Baxter Healthcare is recalling Exactamed Oral Dispensers, Amber: Pharmacy Pack, distributed nationwide in the US. The recall was initiated on 27 Jun 2019 and the FDA has classified it as Class III.
Check your package
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-2432-2019
- FDA event ID
- 83230
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Jun 2019
- FDA classified
- 29 Aug 2019
- Reported
- 4 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 27 Jun 2019 | Recall initiated by company | |
| 29 Aug 2019 | Classified by FDA | +63 days |
| 4 Sep 2019 | 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
EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.
Product as listed by the FDA
EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.
Which lots are affected?
REF H9388105, Lot Numbers: B301N017P, B301N070P, B302M338P, B304N045P REF H9388505, Lot Numbers: B301N023P, B301N049P, B302N077P REF H93884205, Lot Numbers: B301N056P, B302M333P, B303N042P, B307N015P
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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