Recall Z-1733-2019 ยท FMI Needle, Hypodermic, Single Lumen
Smiths Medical ASD Inc.
Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.
| Date | Feb 11, 2019 |
| Status | Terminated |
| Reason | Incorrect needle length and gage. |
| Root cause | Employee error |
| Action | On 2/11/2019 the firm sent notifications of the recall with the following instructions: " 1.Locate and determine the number of affected products in your possession 2.Complete the attached Response Form within 10 days and return it to fieldactions@smiths-medical.com, even if you do not have any of the affected product in your possession. 3.Return affected product to Smiths Medical utilizing the pre-paid shipping labels included with this notice include a copy of your completed Response Form inside EACH BOX of returned product to facilitate processing of credit or replacement. Ensure boxes are s |
| Quantity | 109000 (96,000 USA) |
| Distribution | US Nationwide Distribution - AZ, CA, FL, GA, IL, IN, MA, MN, MO, MS, NJ, NY, PA, RI, SC, TN, TX, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041399 | HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE Smiths Medical Asd, Inc., Jul 28, 2004 |