FDA Enforcement
Class II
Terminated
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.
Recall: Z-0511-2019
·
Reported December 5, 2018
Enforcement
- Recall Number
- Z-0511-2019
- Event ID
- 81460
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Numed Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 5, 2018
- Initiation Date
- October 17, 2018
- Classification Date
- November 28, 2018
- Termination Date
- January 28, 2019
- Address
- 2880 Main Street /Rt 11b, N/A, Hopkinton, NY, 12965, United States
Description
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.
Reason
Instructions for Use booklets were not included on the outer pouch
Code Info
Lot numbers: 6MT-0645, 6MT-0646 Exp. Date: 2023-09-30 UDI: 04046964312861
Distribution
US distribution in the state of PA
Quantity
100 units