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ConvaTec, Inc recalls FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surg
Recalled March 27, 2019 · FDA recall Z-1038-2019 · ConvaTec
Hazard
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. · FDA Class II
Units
124,000 units 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
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.
Manufacturer(s)
ConvaTec, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →