Recall Z-1078-04 ยท FMI Needle, Hypodermic, Single Lumen
Smiths Medical ASD, Inc.
Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2'' Reference Number: 4313
| Date | Jul 20, 2004 (initiated Jun 29, 2004) |
| Status | Terminated |
| Reason | Sterility of product is not assured |
| Root cause | Other |
| Action | Smiths Medical notified consignees by telephone on June 29, 2004. The consignees were asked to immediately quarantine their stock . The Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004. |
| Quantity | 180 CASES (400/CS) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011925 | HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO Sims Portex, Inc., Jul 12, 2001 |