Recall Z-0984-04 ยท LHI Set, I.V. Fluid Transfer
Baxa Corporation
Exacta-Mix Valve Set, Primary Valve Assembly
| Date | Jul 20, 2004 (initiated Apr 30, 2004) |
| Status | Terminated |
| Reason | A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery. |
| Root cause | Other |
| Action | Consignees were notified by phone, fax and letter beginning 4/30/2004. |
| Quantity | 1531 cases (10 per case) |
| Distribution | Nationwide, including 6 military hospitals and two VA facilities. Foreign distribution to Argentina, Brazil, Canada, Columbia, Hong Kong, Korea, Malaysia, Mexico, Panama, Singapore, Taiwan, UK, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900585 | TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP Baxa Corp., Sub. of Cook Group, Inc., Apr 18, 1990 |