Class 2 Device Recall Baxter

• Date Initiated by Firm: July 22, 2022
• Create Date: August 25, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1579-2022
• Recall Event ID: 90658
• Product Classification: Dispenser, liquid medication - Product Code KYX
• Product: Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100, c) 100 pack, REF H93869100
• Code Information: a) 25 pack, REF H93869025, UDI 00085412479965, ALL LOTS; b) 100 pack, REF H938674100, UDI 00085412479811, ALL LOTS; c) 100 pack, REF H93869100, UDI 00085412478944, ALL LOTS
• 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: There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
• FDA Determined Cause: Under Investigation by firm
• Action: Baxter notified its direct consignees by letter on 07/22/2022. The letter explained the issue and potential hazard and provided the following instructions: "1. Locate, isolate/quarantine, and prepare for return any unused affected product from your facility. 2. Contact Baxter Healthcare Center for Service to arrange for return of the products and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. 3. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any inventory. Log in to the portal using the account number listed in the enclosed reply form instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. 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 consumer-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, please contact Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday."
• Quantity in Commerce: 168390 units
• Distribution: Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom.
• 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.