Recall Z-1038-2019— ConvaTec, Inc
Class II · Ongoing
Class II FDA medical device recall by ConvaTec, Inc, initiated 2019-01-09. FDA's recall record names no specific 510(k) clearance for this event. 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: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier..
- Recalling firm
- ConvaTec, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-01-09
- Firm location
- Greensboro, NC, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.