Recall Z-1580-2022 ยท KYX Dispenser, Liquid Medication
Baxter Healthcare Corporation
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, REF H938676100
| Date | Jul 22, 2022 |
| Status | Open, Classified |
| Reason | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| Root 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 |
| Quantity | 9700 units |
| Distribution | Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.