Recall Z-2812-2017— International Medsurg Connection, Inc.

Name: FDA recall Z-2812-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-23

Class II · Terminated

Class II FDA medical device recall by International Medsurg Connection, Inc., initiated 2017-06-23, terminated 2020-08-24. It names one FDA 510(k) clearance: K102584. Product: Hypodermic Needle, 21 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.. Reason: Insufficient documentation to support product sterility claims..

Recalling firm: International Medsurg Connection, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-23
Terminated: 2020-08-24
Firm location: Schaumburg, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K102584 — IMC HYPODERMIC NEEDLEInternational Medsurg Connection·cleared 2011-01-14

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

Hypodermic Needle, 21 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

Reason for recall

Insufficient documentation to support product sterility claims.

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