Z-0511-2019 Class II Terminated
FDA device recall Z-0511-2019 was initiated by Numed Inc on October 17, 2018 and is designated Class II. Reason for recall: Instructions for Use booklets were not included on the outer pouch The recall status is terminated (terminated January 28, 2019). Affected quantity: 100 units.
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