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U.S. Department of Health and Human Services

Class 2 Device Recall Clinical Innovations

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  Class 2 Device Recall Clinical Innovations see related information
Date Initiated by Firm December 30, 2014
Date Posted January 27, 2015
Recall Status1 Terminated 3 on December 28, 2015
Recall Number Z-1014-2015
Recall Event ID 70137
Product Classification Intrauterine tamponade balloon - Product Code OQY
Product Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Code Information Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068
Recalling Firm/
Manufacturer		 Clinical Innovations, LLC
747 W 4170 S
Murray UT 84123-1364
For Additional Information Contact Tom Haueter
801-268-8200
Manufacturer Reason
for Recall		 Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
FDA Determined
Cause 2		 Process design
Action Clinical Innovations sent an "Urgent - Medical Device Recall" letter dated December 31, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They will be instructed to quarantine remaining product. A company representative will visit the hospital and retrieve the product in accordance to instructions detailed on the Representative Recall Reconciliation Instructions. The representative will reconcile the inventory on the Field Reconciliation Form and return the product to Clinical Innovations as indicated on the instructions. The address for the devices to be returned is included on the Representative Recall Reconciliation Instruct Clinical Innovations is working diligently to resolve this issue. In the meantime ,please quarantine any remaining product in your hospital. A company representative will contact you and make arrangements for the return of the product. Clinical Innovations will provide replacement product as soon as it becomes available. If you have any questions,call Clinical Innovations,at 1-(888)268-6222 or your service representative, as is the name of the Company Contact.
Quantity in Commerce 827 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of : Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, Netherlands, Middle East, Scotland, Germany and Wales.
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.
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