Recall Z-0914-03 ยท FPA Set, Administration, Intravascular
Abbott Laboratories HPD/ADD
LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE Ports and Removable 4-Way High Flow Stopcock Microdrip Soluset; Product 19292; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
| Date | Jun 5, 2003 (initiated May 13, 2003) |
| Status | Terminated |
| Reason | IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced. |
| Root cause | Other |
| Action | Recall letter dated 5/12/03 sent to the accounts on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lots to Abbott for credit. |
| Quantity | 7,160 units |
| Distribution | Nationwide. California, Colorado, Connecticut, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Montana, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin. |
| FDA record | Open on fda.gov |