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U.S. Department of Health and Human Services

Class 2 Device Recall DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE

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  Class 2 Device Recall DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE see related information
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
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.
510(K) Database 510(K)s with Product Code = MAV and Original Applicant = SEDAT S.A.
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