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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile EXACTAMED Oral Liquid Dispenser

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 Class 2 Device Recall Sterile EXACTAMED Oral Liquid Dispensersee related information
Date Initiated by FirmFebruary 06, 2018
Create DateMarch 01, 2018
Recall Status1 Terminated 3 on April 02, 2021
Recall NumberZ-0806-2018
Recall Event ID 79090
Product Classification Syringe, irrigating (non dental) - Product Code KYZ
ProductSterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Code Information Lot No. 1203395, Expiration Date 11/30/2019
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		Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
FDA Determined
Cause 2		Employee error
ActionCustomers were notified via letter on about 02/06/2018. Instructions include to locate and remove affected product in inventory, confirm mislabeled 5 mL oral dispensers (Lot number 1203395) in the individual pouch are not mixed together with 1 mL oral dispensers (Product code H93876101) or other stored product, contact Baxter Healthcare Center to arrange return of affected product, and complete and return the customer reply form if purchased directly from Baxter. Also, customer are instructed to notify customers and conduct a consumer-level recall if the affected product was further distributed. Questions and concerns can be directed to the Public Contact, Center for One Baxter with phone number (Toll Free) 800-422-9837 and 847-948-4770, Monday through Friday 8:00 AM to 5:00 PM CST.
Quantity in Commerce2,800 units
DistributionDistributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.
Total Product Life CycleTPLC 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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