Reported Jan 7, 2015 · Terminated
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other…
Perouse Medical
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: PEROUSE MEDICAL · ROUTE DU MANOIR · Ivry Le Temple, N/A · N/A
Is this the product you have?
- Synthes Inflation System (03.804.4135)
- Product UsageInflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter
- Lot codes and dates
- Batch numbers4041354/4062650/4072586
- Amount recalled
- 2184 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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