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
- Sterility
- 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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
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
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 82039This product is part of a recall event; the main page for the event is Nelaton Urinary Catheter, disposable, sterile recalled by ConvaTec.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Nelaton Urinary Catheter, disposable, sterile recalled by ConvaTec | ConvaTec | Sterility | Nationwide | |
| CLASS II | Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit recalled | ConvaTec | Sterility | Nationwide | |
| CLASS II | Forceps Blue, disposable, sterile, 100 eaches per sales unit recalled | ConvaTec | Sterility | Nationwide |
More recalls from ConvaTec
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Esteem Body Soft Convex Urostomy recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
| Device | CLASS II | Aquacel Ag Surgical SP recalled by ConvaTec | ConvaTec | Potency & Assay | Nationwide |
| Device | CLASS II | EsteemBody Drainable recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
| Device | CLASS II | EsteemBody Drainable recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
| Device | CLASS II | EsteemBody Drainable recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
Other Hip & Knee Implants recalls
All 3,110| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |
| Device | CLASS II | Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled | Howmedica Osteonics | Other | Nationwide |