CLASS II ONGOING Device recall · Reported 27 Mar 2019 · FDA Enforcement Report
FilterFlow Suction Handle CH24, 20 eaches per sales unit recalled
ConvaTec is recalling FilterFlow Suction Handle CH24, 20 eaches per sales unit, distributed nationwide in the US. The recall was initiated on 9 Jan 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1038-2019
- FDA event ID
- 82039
- Recalling firm
- ConvaTec, Greensboro, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jan 2019
- FDA classified
- 21 Mar 2019
- Reported
- 27 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 9 Jan 2019 | Recall initiated by company | |
| 21 Mar 2019 | Classified by FDA | +71 days |
| 27 Mar 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is FilterFlow Suction Handle CH24, 20 eaches per sales unit recalled?
Yes. ConvaTec recalled FilterFlow Suction Handle CH24, 20 eaches per sales unit on 9 Jan 2019. The recall is Class II and its status is Ongoing. Recall number Z-1038-2019.
Why was it recalled?
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Which lots are affected?
Product Code/REF Number: 504159; Lot Codes: 176482, 189027
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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