Z-0511-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 5, 2018
- Initiation Date
- October 17, 2018
- Termination Date
- January 28, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units
Product 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 for Recall
Instructions for Use booklets were not included on the outer pouch
Distribution Pattern
US distribution in the state of PA
Code Information
Lot numbers: 6MT-0645, 6MT-0646 Exp. Date: 2023-09-30 UDI: 04046964312861