# FDA recall Z-3030-2018

> **SPS Sterilization, Inc** · Class II · device recall initiated 2018-03-07.

## Product

Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.

## Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

## Distribution

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

## Key facts

- **Recall number:** Z-3030-2018
- **Recalling firm:** SPS Sterilization, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-07
- **Report date:** 2018-09-19
- **Termination date:** 2018-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Nixa, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3030-2018

## Citation

> AI Analytics. FDA recall Z-3030-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-3030-2018. Source: US FDA. Licensed CC0.

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