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U.S. Department of Health and Human Services

Class 2 Device Recall ExactaMed Oral Dispenser

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  Class 2 Device Recall ExactaMed Oral Dispenser see related information
Date Initiated by Firm March 20, 2023
Date Posted April 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-1420-2023
Recall Event ID 91888
Product Classification Syringe, irrigating (non dental) - Product Code KYX
Product ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
Code Information Lot Number B301S356P
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		 ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.
FDA Determined
Cause 2		 Under Investigation by firm
Action Baxter issued an Urgent Medical Device Recall notice to its consignees on 03/20/2023 by USPS. The notice explained the issue and the hazard and requested the following actions be taken: Immediately locate, isolate, and cease all use of the affected product. The product code and lot number can be found on the product carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001, 7:00 am and 6:00 pm Central Time, Monday - Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling. 3. If you received this communication directly from Baxter, please acknowledge receipt by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. 4. If you purchased this product from a distributor, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user level recall of the affected product that you distributed to customers and check the associated box on the customer portal. For general questions regarding this communication, contact Baxter s Center for Service at 888-229-0001, between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
Quantity in Commerce 91,100 units
Distribution US
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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