Recall Z-0858-05 ยท FMI Needle, Hypodermic, Single Lumen
Smiths Medical ASD, Inc.
Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238
| Date | Jun 1, 2005 (initiated May 5, 2005) |
| Status | Terminated |
| Reason | Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8" |
| Root cause | Other |
| Action | Smith Medical notified dealers of the recall on May 5, 2005 by telephone. The remaining customers were notified on May 12, 2005 by telephone. Follow-up letter delivered by Federal Express on May 17, 2005. |
| Quantity | 159 cases (400 per case) =63,600 each. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.