Retiro De Equipo (Recall) de Device Recall Clinical Innovations

Recall

70137

Class 2

Z-1014-2015

2014-12-30

2015-01-27

Terminated

United States

2015-12-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132298

Potential for a balloon leak in all lots of (cts-1000) manufactured since august 2014.

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.