Reported Mar 27, 2019 · Ongoing
FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery…
ConvaTec, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ConvaTec, Inc · 7900 Triad Center Dr Ste 400 · Greensboro, NC · 27409-9076
Is this the product you have?
FilterFlow Suction Handle CH2420 eaches per sales unit
- Product UsageFilter 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
- Lot codes and dates
- Product Code/REF Number504159
- Lot Codes
176482189027
- Amount recalled
- 124,000 units total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
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