FDA-Device2017-07-12Class II
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.
Smiths Medical ASD Inc.
Hazard
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.
Sold states
US Distribution to the state of : IN
Affected count
736,000
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2670-2017Don't want to check this manually?
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