Z-0050-2020Class III

EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF...

Name: Z-0050-2020 EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF...
Creator: Baxter Healthcare Corporation
Published: 2019-08-13
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2019-08-13 / Terminated

FDA source

Baxter Healthcare Corporation began a recall of EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x... on 2019-08-13. FDA classified it as Class III and gives the reason as "Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0050-2020
Classification: Class III
Status: Terminated
Initiated: 2019-08-13
Posted: 2019-10-07
Terminated: 2020-11-23
Recalling firm: Baxter Healthcare Corporation
Product: EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, 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.
Product code: N/A
Reason for recall: Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.
FDA root cause: Under Investigation by firm
Action: The firm issued a safety alert on 08/13/2019 by letter. The letter explained the 5mL syringes were commingled with 3mL syringes and directed the consignee separate the 5mL syringes from the 3mL syringes.
Quantity in commerce: 2,719,200 dispenser units
Distribution: Worldwide distribution - including US Nationwide distribution, and country of Canada.
Product codes and lots: (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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0050-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0050-2020	Class III	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-07

Product code N/A

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)