Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2'' Reference Number: 4313
FDA device recall Z-1078-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Sterility of product is not assured
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 180 CASES (400/CS)
- Distribution
- Nationwide
- Date initiated
- 2004-06-29
- Date posted
- 2004-07-20
- Date terminated
- 2006-05-02
- Location
- Keene, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO (K011925) | Sims Portex, Inc. | 2001-07-12 |