The Recall Desk
LowFDA (Devices)·Z-0511-2019·Announced 2018-12-05

Numed Multi-Track Angiographic Catheter Recall for Missing Instructions

Numed Inc is recalling 100 units of Multi-Track Angiographic Catheters because Instructions for Use booklets were not included on the outer pouch.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a documentation issue (missing Instructions for Use booklets) with no reported injuries or illnesses, fitting the 'Low' severity criteria for documentation issues.

Plain-English summary

Numed Inc is recalling 100 units of Multi-Track Angiographic Catheters (MMTA), Product Code MMTA06100. The recall was initiated because Instructions for Use booklets were not included on the outer pouch.

The affected lots are 6MT-0645 and 6MT-0646, with an expiration date of September 30, 2023. The UDI for the product is 04046964312861. These devices were distributed in the state of Pennsylvania.

The Multi-Track Angiographic Catheter is recommended for use in catheterization for angiography of cardiovascular vessels and chambers, as well as for the injection of contrast medium and pressure measurement. Healthcare providers should verify if they have received these specific lots and contact Numed Inc for further instructions.

The recalled product

Product
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
Manufacturer
Numed Inc
Affected units
100

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot numbers: 6MT-0645
  • 6MT-0646 Exp. Date: 2023-09-30 UDI: 04046964312861

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Numed Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Numed Inc

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