Device 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.
Z-1038-2019
Product summary
- Firm
- ConvaTec, Inc
- Event
- Event 82039
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 124,000 units total
- Official record key
device-enforcement:Z-1038-2019
Official wording
Reason: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Code information: Product Code/REF Number: 504159; Lot Codes: 176482, 189027
Distribution pattern: 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.
Derived failure modes
-
Sterility assurance
breach in the sterile barrier