Reported Jan 7, 2015 · Terminated
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create…
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?
- Bard Caliber (CL3030)
- Inflation Device Product UsageInflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures
- Lot codes and dates
- All lot numbers beginning with Numbers
14031404140514061407
- All lot numbers beginning with Numbers
- Amount recalled
- 24821 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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