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U.S. Department of Health and Human Services

Class 3 Device Recall EXACTAMED Oral Dispensers

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 Class 3 Device Recall EXACTAMED Oral Dispenserssee related information
Date Initiated by FirmAugust 13, 2019
Date PostedOctober 07, 2019
Recall Status1 Terminated 3 on November 23, 2020
Recall NumberZ-0050-2020
Recall Event ID 83544
Product Classification unknown device name - Product Code N/A
ProductEXACTAMED 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.
Code Information (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 
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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 Commerce2,719,200 dispenser units
DistributionWorldwide distribution - including US Nationwide distribution, and country of Canada.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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