Recall Z-0934-03 ยท FPA Set, Administration, Intravascular
Abbott Laboratories HPD/ADD
T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
| Date | Jun 17, 2003 (initiated May 13, 2003) |
| Status | Terminated |
| Reason | The irrigation set was mislabeled with the wrong delivery rate of 8 drops/mL when it actually has a delivery rate of 11 drops/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 | 60 units |
| Distribution | New Orleans, LA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.