The Recall Desk
ModerateFDA (Devices)·Z-1891-2017·Announced 2017-05-10

Perouse Medical Recalls Dolphin Inflation Devices Due to Broken Blister

Perouse Medical is recalling 18,431 Dolphin Inflation Devices because of complaints regarding broken blisters. The devices were distributed in Arizona, Minnesota, and Tennessee.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text only cites complaints regarding broken blisters without reporting any injuries, illnesses, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary actions where harm is not explicitly reported.

Plain-English summary

Perouse Medical is recalling 18,431 units of the Dolphin Inflation Device, specifically the Caliber Inflation Device. The recall is being conducted due to complaints regarding broken blisters. The affected catalog numbers are CL3030-018SNA, 018SND, 0185NA, and 0185ND, with internal code numbers 0185TR, 0185NA, 018SND, 0185NA, and 0185ND.

The affected devices were distributed in the United States, specifically in Arizona (shipped through Belgium to the USA), Minnesota, and Tennessee. The recall is classified as Class II by the U.S. Food and Drug Administration.

Consumers who possess these devices should stop using them and contact Perouse Medical for instructions on how to return or replace the product.

The recalled product

Product
DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
Manufacturer
PEROUSE MEDICAL
Category
Medical Device — Inflation Device
Hazard
Affected units
18,431

Distribution

Distributed in 3 states:

Related recalls

Same manufacturer · PEROUSE MEDICAL

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