# FDA recall Z-0230-2018

> **Terumo Medical Corp** · Class II · device recall initiated 2017-06-07.

## Product

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY

## Reason for recall

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).  This breach of the sterile barrier may compromise the sterility of the sheath.

## Distribution

Nationwide and Canada

## Key facts

- **Recall number:** Z-0230-2018
- **Recalling firm:** Terumo Medical Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-07
- **Report date:** 2017-12-20
- **Termination date:** 2019-04-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerset, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0230-2018

## Citation

> AI Analytics. FDA recall Z-0230-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0230-2018. Source: US FDA. Licensed CC0.

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