Date Initiated by Firm | April 05, 2017 |
Create Date | April 28, 2017 |
Recall Status1 |
Terminated 3 on February 01, 2021 |
Recall Number | Z-1891-2017 |
Recall Event ID |
77100 |
510(K)Number | K042449 |
Product Classification |
Syringe, balloon inflation - Product Code MAV
|
Product | DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND |
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 |
Recalling Firm/ Manufacturer |
PEROUSE MEDICAL ROUTE DU MANOIR Ivry Le Temple France
|
Manufacturer Reason for Recall | Complaints regarding broken blister. |
FDA Determined Cause 2 | 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 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 iblayon@vvgon.com (CC mhpourriere@vygon.com); 7. Communicate the safety information to any person concerned in your company and to all end customers to which the product were transferred. |
Quantity in Commerce | 18,431 |
Distribution | US: AZ (shipped through Belgium to USA), MN, TN |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MAV
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