# FDA recall Z-0213-2018

> **Sterilmed Inc** · Class I · device recall initiated 2017-06-02.

## Product

St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032".  Reprocessed device for single use only, sterile.    Product Usage:  The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

## Reason for recall

Inadequate seal due to lack of adhesive glue

## Distribution

US Nationwide distribution in the states of AR, CO, FL,  MI, OH, TX, and WA.

## Key facts

- **Recall number:** Z-0213-2018
- **Recalling firm:** Sterilmed Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-02
- **Report date:** 2018-01-03
- **Termination date:** 2019-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0213-2018

## Citation

> AI Analytics. FDA recall Z-0213-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0213-2018. Source: US FDA. Licensed CC0.

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