Beacon Tip Centimeter Sizing Catheter Beacon Tip White recall: Impurity Out of Spec
Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic…
Why was Beacon Tip Centimeter Sizing Catheter Beacon Tip White recalled?
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots. Catalog prefixes NR5.0 Catalog/product number; Global/order number Centimeter Sizing: NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-70-P-10S-PIG-CSC-20 G31215 NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-100-P-10S-0-CSC-20 G31214 White Vessel Sizing: NR5.0-35-70-P-10S-PIG-WSC G31224 NR5.0-35-70-P-10S-CFP-WSC G31227 NR5.0-35-70-P-10S-0-WSC G31228 NR5.0-35-65-P-6S-VCF-WSC G31229 NR5.0-35-100-P-10S-PIG-WSC G31226 Vessel Sizing: NR5.0-35-90-P-10S-VCF-CAVA G31233 NR5.0-35-90-P-10S-PIG-CAVA G31231 NR5.0-35-70-P-10S-VCF-CAVA G31232 NR5.0-35-70-P-10S-PIG-CAVA G31230
- Product
- Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic…
- Recalling firm
- Cook Inc.
- Quantity
- 332,255
- Distribution
- Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.
- Recall date
- August 31, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)