Device product
DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
Z-1891-2017
Product summary
- Firm
- PEROUSE MEDICAL
- Event
- Event 77100
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,431
- Official record key
device-enforcement:Z-1891-2017
Official wording
Reason: Complaints regarding broken blister.
Code information: 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 pattern: US: AZ (shipped through Belgium to USA), MN, TN
Derived failure modes
-
Unknown
Complaints regarding broken blister.