Recall Z-0936-03 ยท FPA Set, Administration, Intravascular
Abbott Laboratories HPD/ADD
Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
| Date | Jun 17, 2003 (initiated May 13, 2003) |
| Status | Terminated |
| Reason | The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL |
| Root cause | Other |
| Action | Recall letter dated 5/12/03 sent to the account on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lot to Abbott for credit. |
| Quantity | 4,656 units |
| Distribution | Miami, FL |
| FDA record | Open on fda.gov |