Cook Inc.: Medical Device Recall in 2016 - (Recall #: Z-2620-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures

Product Classification:

Class II

Date Initiated: April 15, 2016

Date Posted: August 31, 2016

Recall Number: Z-2620-2016

Event ID: 74010

Reason for Recall:

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.

Status: Terminated

Product Quantity: 148,334

Code Information:

All Lots. Catalog prefixes / suffixes NPAS-/-SST Catalog/product number; Global/order number NPAS-100-HC-NT-U-SST G52963 NPAS-100-HC-U-SST G52962 NPAS-101-HC-NT-U-SST G23067 NPAS-101-HC-U-SST G23066 NPAS-104-HC-NT-JWG-U-SST G52966 NPAS-104-HC-NT-U-SST G52965 NPAS-104-HC-U-SST G52964 NPAS-105-HC-NT-U-SST G52967 NPAS-108-HC-NT-U-SST G25516 NPAS-120-HC-NT-U-SST G25517 NSSW-4.0-18-NPAS-100-HC-SST G34253

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated