| Class 2 Device Recall Bridge Occlusion Balloon | |
Date Initiated by Firm | October 31, 2016 |
Date Posted | November 28, 2016 |
Recall Status1 |
Terminated 3 on April 18, 2017 |
Recall Number | Z-0663-2017 |
Recall Event ID |
75617 |
510(K)Number | K140775 |
Product Classification |
Catheter, intravascular occluding, temporary - Product Code MJN
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Product | Bridge Occlusion Balloon. Model: 590-001
Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended. |
Code Information |
FMN16E11A; FMN16E18A; FMN16E25A; FMN16F01A; FMN16F08A; FMN16F15A FMN16F22A; FMN16G13A; FMN16G19A; FMN16G25A; FMN16H04A; FMN16H23A; FMN16J27A |
Recalling Firm/ Manufacturer |
Spectranetics Corporation 9965 Federal Drive Colorado Springs CO 80921-3617
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For Additional Information Contact | Lindsay K Pack 719-447-2469 |
Manufacturer Reason for Recall | Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging. |
FDA Determined Cause 2 | Packaging |
Action | Spectranectics sent an Urgent Medical Device Recall letter dated October 31, 2016, to all affected consignees. Consignees were instructed to discontinue use of the potentially impacted lots and return the product for replacement. Consignees were also instructed to complete the attached Acknowledgement and Receipt Form to facilitate the product return of any remaining product in inventory. Customers with questions were instructed to call 1-800-231-0978, Option 2. For questions regarding this recall call 719-651-8517. |
Quantity in Commerce | 873 units |
Distribution | Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand. |
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 = MJN
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