Recall Z-2670-2017— Smiths Medical ASD Inc.

Name: FDA recall Z-2670-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-04

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2017-04-04, terminated 2019-08-05. It names one FDA 510(k) clearance: K923127. 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.. 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..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-04
Terminated: 2019-08-05
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K923127 — NEEDLE-PRO CARTRIDGEConcord/Portex·cleared 1993-04-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.