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Recall Observatory FDA recall evidence

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

January 09, 2019

Class II

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

    reason.sterility_assurance · v1.0.0

    breach in the sterile barrier