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U.S. Department of Health and Human Services

Class 2 Device Recall MultiTrack Angiographic Catheter (MMTA)

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  Class 2 Device Recall MultiTrack Angiographic Catheter (MMTA) see related information
Date Initiated by Firm October 17, 2018
Create Date November 28, 2018
Recall Status1 Terminated 3 on January 28, 2019
Recall Number Z-0511-2019
Recall Event ID 81460
510(K)Number K952984  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product 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.
Code Information Lot numbers: 6MT-0645, 6MT-0646 Exp. Date: 2023-09-30 UDI: 04046964312861
Recalling Firm/
Manufacturer		 Numed Inc
2880 Main Street /Rt 11b
Hopkinton NY 12965
For Additional Information Contact
315-328-4491
Manufacturer Reason
for Recall		 Instructions for Use booklets were not included on the outer pouch
FDA Determined
Cause 2		 Labeling design
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..
Quantity in Commerce 100 units
Distribution US distribution in the state of PA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = MAP MEDICAL EQUIPMENT, INC.
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