# FDA recall Z-1007-2018

> **Medtronic Minimally Invasive Therapies Group** · Class II · device recall initiated 2017-10-14.

## Product

MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis  Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.

## Reason for recall

Medtronic is voluntarily recalling one lot of its  MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our supplier that one production lot of MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays was inadvertently shipped to Medtronic and distributed without being sterilized.

## Distribution

U.S.

## Key facts

- **Recall number:** Z-1007-2018
- **Recalling firm:** Medtronic Minimally Invasive Therapies Group
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-14
- **Report date:** 2018-03-21
- **Termination date:** 2018-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1007-2018

## Citation

> AI Analytics. FDA recall Z-1007-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-1007-2018. Source: US FDA. Licensed CC0.

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