Class 2 Device Recall ExactaMed Oral Dispenser

• Date Initiated by Firm: March 20, 2023
• Date Posted: April 20, 2023
• Recall Status: Open, 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
• FEI Number: 1417572
• 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: 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.