Recall Z-2827-2017— International Medsurg Connection, Inc.

Name: FDA recall Z-2827-2017
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: K102969. Product: Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case. 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

K102969 — IMC PISTON SYRINGESInternational Medsurg Connection·cleared 2010-12-20

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

Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case

Reason for recall

Insufficient documentation to support product sterility claims.

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