Recall Z-0510-2019— Numed Inc

Name: FDA recall Z-0510-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-17

Class II · Terminated

Class II FDA medical device recall by Numed Inc, initiated 2018-10-17, terminated 2019-01-28. It names one FDA 510(k) clearance: K952984. Product: Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 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.. Reason: Instructions for Use booklets were not included on the outer pouch.

Recalling firm: Numed Inc
Classification: Class II
Status: Terminated
Initiated: 2018-10-17
Terminated: 2019-01-28
Firm location: Hopkinton, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K952984 — MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F)Map Medical Equipment, Inc.·cleared 1996-01-29

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

Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 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.

Reason for recall

Instructions for Use booklets were not included on the outer pouch

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