# FDA recall Z-2007-2020

> **Edwards Lifesciences, LLC** · Class II · device recall initiated 2020-03-27.

## Product

Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181

## Reason for recall

Sterile catheter kit packaging compromised.

## Distribution

US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.

## Key facts

- **Recall number:** Z-2007-2020
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-27
- **Report date:** 2020-05-20
- **Termination date:** 2021-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2007-2020

## Citation

> AI Analytics. FDA recall Z-2007-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2007-2020. Source: US FDA. Licensed CC0.

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