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U.S. Department of Health and Human Services

Class 3 Device Recall EXACTAMED Oral Dispenser Pharmacy Pack

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  Class 3 Device Recall EXACTAMED Oral Dispenser Pharmacy Pack see related information
Date Initiated by Firm June 27, 2019
Create Date August 29, 2019
Recall Status1 Terminated 3 on November 02, 2020
Recall Number Z-2432-2019
Recall Event ID 83230
Product Classification Dispenser, liquid medication - Product Code KYX
Product EXACTAMED Oral Dispensers, 5mL, AMBER:
PHARMACY PACK, REF H9388505, x500
PHARMACY PACK, REF H9388105, x100
COST CONTAINMENT, REF H93884205, x1500
Code Information REF H9388105, Lot Numbers: B301N017P, B301N070P, B302M338P, B304N045P REF H9388505, Lot Numbers: B301N023P, B301N049P, B302N077P REF H93884205, Lot Numbers: B301N056P, B302M333P, B303N042P, B307N015P
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm disseminated a safety alert to their consignees on 06/27/2019 by letter. The letter explained the 5mL syringes were commingled with 10mL syringes and directed the consignee separate the 5mL syringes from the 10mL syringes.
Quantity in Commerce 2192000 syringes
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
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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