DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
Recall
- Recall Number
- Z-1891-2017
- Event Number
- 77100
- Firm
- PEROUSE MEDICAL ROUTE DU MANOIR Ivry Le Temple France
- FEI Number
- 3006942524
- Product Code
- MAV
- Status
- Terminated
- Root Cause
- Packaging change control
- Initiated
- April 5, 2017
- Terminated
- February 1, 2021
Description
DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
Complaints regarding broken blister.
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 deteriorate in time. If, to date, there is no crack in the blister, then the integrity of the product is not compromised; 4- Do not use the non-compliant products; 5. Complete and sign the attached reply form, then return it within 5 working days following the reception of this letter, and keep a copy; 6. Contact customer service for the modalities of return, replacement and associated support at +33 (0)4.72.39.74.13 or by fax at +33 (0}3.44.08.17.67 or by email at [email protected] (CC [email protected]); 7. Communicate the safety information to any person concerned in your company and to all end customers to which the product were transferred.
US: AZ (shipped through Belgium to USA), MN, TN
18,431