# FDA recall Z-1036-2019

> **ConvaTec, Inc** · Class II · device recall initiated 2019-01-09.

## Product

Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM    Product Usage:  Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum to assist in the drainage of gastric contents, decompression of the stomach or duodenum, or for obtaining a specimen of gastric contents. The device is intended to administer medication or fluids, and enteral feeding.

## Reason for recall

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

## Distribution

Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI.  and the countries of Algeria, Australia, Austria, Belgium, Canada, Croatia, Czechia, Czech Republic, Denmark, Egypt, Estonia, Finland, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kenya, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.

## Key facts

- **Recall number:** Z-1036-2019
- **Recalling firm:** ConvaTec, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-01-09
- **Report date:** 2019-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greensboro, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1036-2019

## Citation

> AI Analytics. FDA recall Z-1036-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1036-2019. Source: US FDA. Licensed CC0.

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