ConvaTec, Inc recalls FilterFlow Suction Handle CH24, 20 eaches per sales unit.
Recalled 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.
Hazard / Issue
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Issued by
FDA
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