Reported Oct 16, 2019 · Terminated

EXACTAMED Oral Dispensers, 5mL, AMBER

Baxter Healthcare Corporation

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

EXACTAMED Oral Dispensers, 5mL, AMBER

3 of 3 products

Products covered by this recall
Model / numberProduct as published
H9388105(a) PHARMACY PACK, , x 100
H9388505(b) PHARMACY PACK, , x 500
H93884205(c) COST CONTAINMENT, , x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent administration of liquid medication and nutrition to humans through the patient s mouth.
Lot codes and dates
  • (a) REF H9388105
  • Lot Numbers
    • B301N017P
    • B301N070P
    • B304N045P (b) REF H9388505
  • Lot Numbers
    • B301N023P
    • B301N049P
    • B302N077P
    • B303N108P (c) REF H93884205
  • Lot Numbers
    • B301N056P
    • B303N042P
    • B307N015P
Amount recalled
2,719,200 dispenser units

Where it was sold

  • Nationwide

Why it was recalled

Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 23, 2020 · Data as of Sep 19, 5:30 PM UTC

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