Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2670-2017 — 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.

U.S. FDA — Device Enforcement · United States · 2017-04-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2670-2017
Date of alert
2017-04-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smiths Medical ASD Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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