# FDA recall Z-1035-2019

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

## Product

Forceps Blue, disposable, sterile, 100 eaches per sales unit.    Product Usage:  Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forceps may be used in conditions where it is difficult to grasp small objects by hand and increased precise function is required. Applications in which sterile forceps are commonly used include wound care: e.g. gripping, debridement procedures, removal of sutures, arrangement of dressing procedure pack contents, dressing wounds, including cavity wounds and removal of wound tissue.

## 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-1035-2019
- **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-1035-2019

## Citation

> AI Analytics. FDA recall Z-1035-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1035-2019. Source: US FDA. Licensed CC0.

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