CLASS II Device recall · Reported 10 May 2017 · FDA Enforcement Report
Dolphin Inflation Device Caliber Inflation Device recalled
Perouse Medical is recalling Dolphin Inflation Device Caliber Inflation Device, distributed in Arizona, Minnesota, Tennessee. The recall was initiated on 5 Apr 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1891-2017
- FDA event ID
- 77100
- Recalling firm
- Perouse Medical, Ivry Le Temple
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Apr 2017
- FDA classified
- 28 Apr 2017
- Reported
- 10 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 Apr 2017 | Recall initiated by company | |
| 28 Apr 2017 | Classified by FDA | +23 days |
| 10 May 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaints regarding broken blister.
Product as listed by the FDA
DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
Where it was distributed
US: AZ (shipped through Belgium to USA), MN, TN
Questions about this recall
Why was it recalled?
Complaints regarding broken blister.
Which lots are affected?
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
Where was it sold?
US: AZ (shipped through Belgium to USA), MN, TN
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Perouse Medical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Synthes Inflation System (03.804.4135) recalled by Perouse Medical | Perouse Medical | Other | Nationwide |
| Device | CLASS II | Bard Caliber (CL3030) Inflation Device recalled by Perouse Medical | Perouse Medical | Other | Nationwide |
| Device | CLASS II | Perouse Flamingo recalled by Perouse Medical | Perouse Medical | Other |
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