# FDA recall Z-2280-2021

> **Edwards Lifesciences, LLC** · Class II · device recall initiated 2021-07-09.

## Product

Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495    *NOT DISTRIBUTED WITHIN THE US

## Reason for recall

There is a potential for internal leaks within catheters.

## Distribution

US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL,  OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Iman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, Canada

## Key facts

- **Recall number:** Z-2280-2021
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-09
- **Report date:** 2021-08-18
- **Termination date:** 2024-01-29

- **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-2280-2021

## Citation

> AI Analytics. FDA recall Z-2280-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2280-2021. Source: US FDA. Licensed CC0.

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