Recall Z-1197-2010 ยท LHI Set, I.V. Fluid Transfer
Baxa Corporation
Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation, Englewood CO. Intended as tubing for use in compounding, used to connect up to 24 source ingredients.
| Date | Mar 23, 2010 (initiated Feb 10, 2010) |
| Status | Terminated |
| Reason | Molding defect in the valve body causes leaking. |
| Root cause | Nonconforming Material/Component |
| Action | Baxa Corporation notified customers of the affected product by letter beginning February 10, 2010. Users were instructed to return all affected product to the firm. For further information, contact Baxa Corporation at 1-303-617-2242. |
| Quantity | 3230 cases; 32300 units (10 units/case) |
| Distribution | Nationwide Distribution -- Including AL, AR, AZ, CA, CO, DC, MN, IL, NY, DE, FL, PA, IN, TN, MS, MO, TX, MI, MA, MT, MO, SC, VA, WV, NJ, OH, CT, MO, NV, LA, WA, WI, GA, OK, NE, NH, NC, MD, KS, UT, IA, KY, HI, OR, SC, ME and SD. |
| 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 |