—#155955

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.

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K923127
Affected lot / code info: 3297460,3297461 Model No. EL1915. 3297458,3297459,3297465, 3297466,3297467 Model No. SB5021.

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: US Distribution to the state of : IN

Timeline

Recall initiated: 2017-04-04
Terminated: 2019-08-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155955. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.