Recall Z-2670-2017 ยท FMI Needle, Hypodermic, Single Lumen
Smiths Medical ASD Inc.
Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
| Date | Apr 4, 2017 |
| Status | Terminated |
| Reason | Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smiths Medical incoming inspection. The syringe assemblies were used to manufacture seven (7) finished good lots of Hypodermic Needle Pro needles, Smiths Medical part numbers EL 1915 and SB5021. |
| Root cause | Process control |
| Action | Smiths Medical sent an "Urgent Medical Device Recall Notice" dated April 04, 2017. The letter was addressed to Quality Assurance Manager & Associate Sourcing Consultant. The letter listed the Affected devices described the Reason for Recall, & Risk to Health. Requested consignee to complete Urgent Medical Device Recall Response Form within 10 days of receipt and send it to: fieldactions@smithsmedical.com. For further questions, please call (603) 352-3812 |
| Quantity | 736,000 |
| Distribution | US Distribution to the state of : IN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923127 | NEEDLE-PRO CARTRIDGE Concord/Portex, Apr 29, 1993 |