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.
This recall has been terminated (originally issued October 7, 2019).
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- August 13, 2019
- Posted
- October 7, 2019
- Terminated
- November 23, 2020
- Recall Number
- Z-0050-2020
- Quantity
- 2,719,200 dispenser units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.
Distribution
Worldwide distribution - including US Nationwide distribution, and country of Canada.
Lot / Code Info
(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
Root Cause
Under Investigation by firm
Action Taken
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.
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