Remove affected devices from service
San Diego, CA (PRWEB) August 22, 2014
AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Diamondback 360 Peripheral Orbital Atherectomy System.
The US FDA announced on August 19, that certain lots of the Diamondback 360 Peripheral Orbital Atherectomy Systems, model number DPB-125MICRO145 (Part number 7-10003), by Cardiovascular Systems, are recalled because they may contain defective saline sheaths that could fracture during use and could possibly block blood vessels. Diamondback 360 Peripheral Orbital Atherectomy System is a high-speed cutting tool inserted via a catheter into blood vessel and it is used to reestablish blood flow in narrowed arteries or arterio-venous dialysis shunts.
The affected lots are: 100573, 100575, 100674, 100676, 100678, 100680.
The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.
Taking into consideration the latest developments, AttorneyOne.com monitor daily and update the website providing accurate information on all relevant FDA safety alerts. Sean Burke, director of Media Relations at AttorneyOne.com, adds “we are determined to keep an eye on FDA announcements concerning Diamondback 360 Peripheral Orbital Atherectomy System and inform the public. For that reason", he continues, "our focus should squarely fall on investigating these safety alerts and getting the word out.”
As the FDA notes “On May 27, 2014, Cardiovascular Systems sent an 'Urgent Medical Device Recall' letter to their customers. The letter identified the problem and the specific products affected by the recall. The letter advises customers to:
- Remove affected devices from service.
- Complete and return a 'Customer Acknowledgement Form.'
- Return affected devices to Cardiovascular Systems”
AttorneyOne.com has further information on Diamondback 360 Peripheral Orbital Atherectomy System at the website including the latest major drug, food, and medical products law news.
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