Multi-Track recallZ-0510-2019 · Numed Inc · initiated Oct 17, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Numed Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Instructions for Use booklets were not included on the outer pouch
FDA root cause category: Labeling design
What the company is doing
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..
Recall details
- Recall number
- Z-0510-2019
- Status
- Terminated
- Initiated by the company
- Oct 17, 2018
- Recalling firm
- Numed Inc
- Quantity
- 100 units
- Product code
- DQO
- FDA submissions
- K952984
- Distribution
- US distribution in the state of PA
Product description
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.
Code information (models, lots, serial numbers)
Lot numbers: 5MT-1264, 5MT-1265 Exp. Date: 2023-09-30 UDI: 04046964312700
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Multi-Track™ 615001B Braun Interventional Systems, Inc · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 81460).
- Z-0511-2019 · TerminatedMulti-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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