Recall Z-0510-2019
Numed Inc · initiated October 17, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 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.
Codes / lots: Lot numbers: 5MT-1264, 5MT-1265 Exp. Date: 2023-09-30 UDI: 04046964312700
Reason for recall
Instructions for Use booklets were not included on the outer pouch
FDA-determined cause: Labeling design
Action taken
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..
Details
- Recall number
- Z-0510-2019
- Initiated
- October 17, 2018
- Terminated
- January 28, 2019
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Quantity
- 100 units
- Distribution
- US distribution in the state of PA
- Recalling firm
- Numed Inc, Hopkinton, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0511-2019 Class II | Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage:…Instructions for Use booklets were not included on the outer pouch | 10/17/2018Terminated |