Recall Z-1570-2022 ยท LHI Set, I.V. Fluid Transfer
Baxter Healthcare Corporation
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.
| Date | Aug 24, 2022 (initiated Jul 14, 2022) |
| Status | Open, Classified |
| Reason | There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. |
| Root cause | Process control |
| Action | Baxter issued an URGENT DEVICE CORRECTION notice by mail on 07/14/2022. Baxter sent a follow-up notice dated 6/28/2023, stating Customers may return to using all 24 ports on their compounders when using newly manufactured EXACTAMIX 2400 Valve Sets (product code H938724, lot 60459942 and sequentially higher). Contact Baxter Technical Support M-F 8am-7pm ET at 800-678-2292 for help establishing/restoring a 24-port configuration for compounding, if not on drop-down menu. Lot numbers 60459941 and lower MUST use only 20 ports, omitting ports 1-4. For these sets: Baxter Technical Service added |
| Quantity | 448,960 units |
| Distribution | Worldwide distribution: US Nationwide, Canada, Uruguay, Argentina, Brazil, Colombia, Dominican Republic, Panama, Puerto Rico, Hong Kong, Taiwan, Korea, United Kingdom, Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Kuwait, Netherlands, Oman, Pola |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002705 | EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 Baxa Corp., Mar 28, 2001 |