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 Recall Z-2670-2017 · Posted None
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Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeFMI
Date Initiated2017-04-04
Date Terminated2019-08-05
Product Quantity736,000
Reason for Recall
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.
Firm 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: [email protected].
For further questions, please call (603) 352-3812
Root Cause
Process control
Distribution Pattern
US Distribution to the state of : IN
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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