Micromedics, Inc. recalls Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide

Recall date

October 20, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1817-2017

FDA classification

Class II

Brand / firm

Micromedics, Inc.

Sold / distributed

AL, CA, FL, MS, NC, NJ, NY, TN, and TX. Outside the US: Israel

Why it was recalled

The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assurance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide