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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Hazard
- Affected units
- 18,431
Distribution
Related recalls
Same manufacturer · PEROUSE MEDICAL
See all →- HighBard Caliber Inflation Device Recalled for Pressure Limitations
FDA (Devices) · 2015-01-07
- ModeratePerouse Medical Recalls Synthes Inflation System Due to Pressure Limitations
FDA (Devices) · 2015-01-07
- HighPerouse Flamingo Inflation Devices Recalled for Potential Water-Tightness Defect
FDA (Devices) · 2014-07-30
Similar recalls
- HighVascular Solutions Recalls Dolphin Inflation Devices Due to Sterile Barrier Defect
FDA (Devices) · 2017-06-07
- HighPerouse Flamingo Inflation Devices Recalled for Potential Water-Tightness Defect
FDA (Devices) · 2014-07-30
- SevereDeRoyal Dolphin Inflation Device Recalled for Sterility Assurance Defect
FDA (Devices) · 2017-07-05
- HighBard Caliber Inflation Device Recalled for Pressure Limitations
FDA (Devices) · 2015-01-07
- ModeratePerouse Medical Recalls Synthes Inflation System Due to Pressure Limitations
FDA (Devices) · 2015-01-07
- ModerateBoston Scientific Recalls Encore 26 Inflation Devices Due to Cracked Trays
FDA (Devices) · 2017-08-23