ConvaTec, Inc recalls Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices

Recalled March 27, 2019 · FDA recall Z-1035-2019 · ConvaTec

Hazard

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. · FDA Class II

Units

24,822,068 devices total

Sold at

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.

Description

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

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.

Manufacturer(s)

ConvaTec, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →