Recall Z-0082-06 ยท LHI Set, I.V. Fluid Transfer
Medrad Inc
Medrad Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT
| Date | Oct 21, 2005 (initiated Sep 20, 2005) |
| Status | Terminated |
| Reason | stress crack on the stopcock |
| Root cause | Other |
| Action | The recalling firm issued letters dated 9/20/05 to the hospitals and sales representative informing them of the problem and the need to return the product. |
| Quantity | 1575 units |
| Distribution | The products were shipped to medical facilities in CA, CO, DE, FL, IL, MA, NC, OH, PA, and VA. The products were also shipped to sales representatives in CA, CO, FL, MA, MN, MO, OK, PA, SC, and WI. The products were sent to the recalling firm''s distributors in the Netherlands, Denmark, France, and |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050456 | MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM Medrad, Inc., Jun 17, 2005 |