Medical device recalls Moderate risk

Numed Inc recalls Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization…

Recall date
October 17, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0511-2019
FDA classification
Class II
Brand / firm
Numed Inc
Sold / distributed
US distribution in the state of PA

Why it was recalled

Instructions for Use booklets were not included on the outer pouch

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

What was recalled

Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.

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