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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Event Detail

Event ID 63407
Product Type Devices
Status Ongoing
Recalling Firm Terumo Cardiovascular Systems Corporation
City Ann Arbor
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-21
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia,United Arab Emirates (UAE), Singapore, USA, Malaysia, BELGIUM, Japan, and CANADA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
24 Fr 8mm Soft Flow Ang Wire W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. catalog number: 5762 and lot number: 0570466 and 0589212 Class II Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. 5760 total products Z-0461-2013
18 Fr 6mm Sft Flow Ang Wire W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. catalog number: 7072 and lot number: 0602542, 0614871, and 0620810. Class II Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. 5760 total Z-0460-2013
18 Fr 6mm Sft Flow Angled Wire The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. catalog number: 7071 and lot number: 0597322, 0602541, 0610241, 0615610, 0619197, 0620809, and 0620810. Class II Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. 5760 total Z-0459-2013
24 Fr 8mm Sft Flow Straight The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. catalog number: 5847 and lot number: 0582251 and 0586068 Class II Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. 5760 total Z-0458-2013
24 Fr 8mm Sft Flow Straight Wir The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use catalog number: 5843 and lot number: 0584961 Class II Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. 5760 total Z-0457-2013
24 Fr 8mm Sft Flow Str Wire W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. catalog number: 5841 and 5845 and lot number: 0581536 and 0581138. Class II Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. 5760 total Z-0456-2013
24 Fr 8mm Soft Flow Ang W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. catalog number: 5774 and lot number: 0595116. Class II Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. 5760 total units Z-0462-2013
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