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Terminated

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.

FDA Recall Z-0510-2019 · Posted None

Recalling FirmNumed Inc
Recall StatusTerminated
Product CodeDQO
Date Initiated2018-10-17
Date Terminated2019-01-28
Product Quantity100 units

Reason for Recall

Instructions for Use booklets were not included on the outer pouch

Firm Action

NuMED issued recall notification letter and response form on 10/17/2018 via email to the one distributor and followed up by a hard copy of the letter and response form sent via UPS Next Day Air. The letter identified the affected product, problem and actions to be taken. The customer was instructed to return affected product..

Root Cause

Labeling design

Distribution Pattern

US distribution in the state of PA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952984MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F)Map Medical Equipment, Inc. · 1996-01-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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