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U.S. Department of Health and Human Services

Class 2 Device Recall Dolphin Inflation Device

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  Class 2 Device Recall Dolphin Inflation Device see related information
Date Initiated by Firm June 07, 2017
Create Date June 29, 2017
Recall Status1 Terminated 3 on July 22, 2020
Recall Number Z-2639-2017
Recall Event ID 77519
510(K)Number K042449  
Product Classification Syringe, balloon inflation - Product Code MAV
Product DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO,
Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
Code Information Lot Number 15125173
Recalling Firm/
DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact
Manufacturer Reason
for Recall
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action DeRoyal issued an Urgent Recall Notice dated June 7, 2017, to all affected customers. The customers were asked to identify the affected products and return the provided notice of return form back to DeRoyal indicating if replacement or credit is requested. Customers with questions were instructed to call 888-938-7828 or email recalls@deroyal.com. For questions regarding this recall call 865-938-7828.
Quantity in Commerce 426 units
Distribution Nationwide Distribution to MD, NY, and IL
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.