Recall Z-1891-2017 ยท MAV Syringe, Balloon Inflation
PEROUSE MEDICAL
DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
| Date | Apr 5, 2017 |
| Status | Terminated |
| Reason | Complaints regarding broken blister. |
| Root cause | Packaging change control |
| Action | Consignees were notified of the recall on April 5, 2017. They were informed of the issue and asked to take the following steps: 1. Inspect your stock to determine if you still have in your ownership devices among which the references and batch codes are listed in front page; 2. Control the potential damage of the blister according to the pictures above and the instructions mentioned on the labeling and the Instruction For Use: any damaged and/or cracked blister must be immediately discarded; 3. Use the compliant products without risk, after control. Indeed, the primary packaging will not dete |
| Quantity | 18,431 |
| Distribution | US: AZ (shipped through Belgium to USA), MN, TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042449 | DOLPHIN INFLATION DEVICE Sedat S.A., Apr 18, 2005 |