Device product
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.
Z-2670-2017
Product summary
- Event
- Event 77402
- Status
- Terminated
- Classification
- Class II
- Quantity
- 736,000
- Official record key
device-enforcement:Z-2670-2017
Official wording
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.
Code information: 3297460,3297461 Model No. EL1915. 3297458,3297459,3297465, 3297466,3297467 Model No. SB5021.
Distribution pattern: US Distribution to the state of : IN
Derived failure modes
-
Unknown
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.