Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- July 22, 2022
- Recall Number
- Z-1577-2022
- Quantity
- 10140 units
- Firm Location
- Deerfield, IL
Reason for Recall
There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
Distribution
Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom.
Lot / Code Info
REF H938671100, UDI 00085412479750
Root Cause
Under Investigation by firm
Action Taken
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."