Reported May 10, 2017 · Terminated

DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE…

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

Is this the product you have?

  • DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE
  • Catalog NumberCL3030- 018SNA- 018SND 0185NA 0185ND
  • INTERNAL CODE NUMBER0185TR- 0185NA- 018SND 0185NA 0185ND
Lot codes and dates
  • 1 5045606 - 15055430 - 15065340 - 15065685 -15065744- 15065858- 15065970- 15075121 - 15075265 - 15075411- 15075821 - 1 5075851 - 15075942 - 15085001 - 15085075 -15085378- 15085435 -15085515- 15085555 -15105052- 15125214- 16015267- 16025034- 16025640
Amount recalled
18,431

Where it was sold

Why it was recalled

Complaints regarding broken blister.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 1, 2021 · Data as of Sep 19, 4:45 PM UTC

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