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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DQO
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