# FDA recall Z-1038-2019

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

## Product

FilterFlow Suction Handle CH24, 20 eaches per sales unit.    Product Usage:  Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments, chips, cement, marrow and blood clots without blocking the suction device, using a combination of suctioning and filtering.

## 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-1038-2019
- **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-1038-2019

## Citation

> AI Analytics. FDA recall Z-1038-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1038-2019. Source: US FDA. Licensed CC0.

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