FDA Recall
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
·
Initiated October 17, 2018
Recall
- Recall Number
- Z-0511-2019
- Event Number
- 81460
- Firm
- Numed Inc
- FEI Number
- 1318694
- Product Code
- DQO
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- October 17, 2018
- Terminated
- January 28, 2019
- Address
- 2880 Main Street, Rt 11b, Hopkinton, NY, 12965
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
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..
Distribution
US distribution in the state of PA
Quantity
100 units