# FDA recall Z-1962-2020

> **W. L. Gore & Associates Inc.** · Class II · device recall initiated 2019-11-18.

## Product

Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile.  The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.

## Reason for recall

The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.

## Distribution

All distribution is foreign to the following countries:  Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Norway, Spain, Sweden, Switzerland, and the UK.

## Key facts

- **Recall number:** Z-1962-2020
- **Recalling firm:** W. L. Gore & Associates Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-18
- **Report date:** 2020-05-20
- **Termination date:** 2020-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Phoenix, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1962-2020

## Citation

> AI Analytics. FDA recall Z-1962-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1962-2020. Source: US FDA. Licensed CC0.

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