FDA Enforcement
Class II
Terminated
DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
Recall: Z-1891-2017
·
Reported May 10, 2017
Enforcement
- Recall Number
- Z-1891-2017
- Event ID
- 77100
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- PEROUSE MEDICAL
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 10, 2017
- Initiation Date
- April 5, 2017
- Classification Date
- April 28, 2017
- Termination Date
- February 1, 2021
- Address
- ROUTE DU MANOIR, Ivry Le Temple, N/A, France
Description
DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
Reason
Complaints regarding broken blister.
Code Info
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
Distribution
US: AZ (shipped through Belgium to USA), MN, TN
Quantity
18,431