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/ Manufacturer |
DeRoyal Industries Inc 200 Debusk Ln Powell TN 37849-4703
|
For Additional Information Contact |
865-938-7828
|
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.
|