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Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended fo...

FDA Device Recall #Z-2614-2016 — Class II — April 15, 2016

Recall Summary

Recall Number Z-2614-2016
Classification Class II — Moderate risk
Date Initiated April 15, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cook Inc.
Location Bloomington, IN
Product Type Devices
Quantity 298,340

Product Description

Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.

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.

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.

Lot / Code Information

All Lots. Catalog prefixes SCBR5.0, SCBR5.5, and SCBR6.5 Catalog/product number; Global/order number SCBR5.0-38-100-P-NS-0 G12005 SCBR5.0-38-100-P-NS-C2 G12008 SCBR5.0-38-100-P-NS-DAV G11996 SCBR5.0-38-100-P-NS-H1 G11991 SCBR5.0-38-100-P-NS-HN4 G23693 SCBR5.0-38-100-P-NS-JB1 G11997 SCBR5.0-38-100-P-NS-JB2 G11998 SCBR5.0-38-100-P-NS-KMP G28535 SCBR5.0-38-100-P-NS-MAN G11999 SCBR5.0-38-100-P-NS-MPA G12002 SCBR5.0-38-100-P-NS-NTR G23695 SCBR5.0-38-100-P-NS-RVC G43120 SCBR5.0-38-100-P-NS-SIM1 G12000 SCBR5.0-38-100-P-NS-SIM2 G11992 SCBR5.0-38-100-P-NS-SIM3 G12001 SCBR5.0-38-100-P-NS-TEGT G23694 SCBR5.0-38-100-P-NS-VERT G12007 SCBR5.0-38-100-P-NS-VTK G13163 SCBR5.0-38-125-P-NS-0 G32366 SCBR5.0-38-125-P-NS-DAV G13413 SCBR5.0-38-125-P-NS-H1 G23696 SCBR5.0-38-125-P-NS-JB1 G13530 SCBR5.0-38-125-P-NS-SIM1 G32369 SCBR5.0-38-125-P-NS-SIM2 G13200 SCBR5.0-38-125-P-NS-TEGT G32367 SCBR5.0-38-125-P-NS-VERT G12168 SCBR5.0-38-125-P-NS-VTK G12082 SCBR5.0-38-40-P-NS-KMP G11993 SCBR5.0-38-65-P-NS-0 G12009 SCBR5.0-38-65-P-NS-C1 G12003 SCBR5.0-38-65-P-NS-C2 G11994 SCBR5.0-38-65-P-NS-C3 G12004 SCBR5.0-38-65-P-NS-DAV G23688 SCBR5.0-38-65-P-NS-H1 G13319 SCBR5.0-38-65-P-NS-KMP G12156 SCBR5.0-38-65-P-NS-LEV1 G12798 SCBR5.0-38-65-P-NS-MPA G23689 SCBR5.0-38-65-P-NS-RC2 G13272 SCBR5.0-38-65-P-NS-RDC G13092 SCBR5.0-38-65-P-NS-RIM G11995 SCBR5.0-38-65-P-NS-SIM1 G12716 SCBR5.0-38-65-P-NS-SIM2 G23691 SCBR5.0-38-65-P-NS-TC G36320 SCBR5.0-38-65-P-NS-TC-BNK G36322 SCBR5.0-38-65-P-NS-TEGT G12179 SCBR5.0-38-80-P-NS-C2 G12006 SCBR5.0-38-80-P-NS-MPA G23692 SCBR5.0-38-80-P-NS-RH G36214 SCBR5.0-38-80-P-NS-VS G13431 SCBR5.0-38-80-P-NS-VS1 G13432 SCBR5.0-38-80-P-NS-VS2 G13433 SCBR5.0-38-80-P-NS-VS3 G13434 SCBR5.5-35-60-P-NS-PATEL G51570 SCBR6.5-35-60-P-NS-PATEL G51571

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Z-0414-2022 Class II Skinny Needle with Chiba Tip. RPN 090010, 09001... Oct 13, 2021
Z-0222-2022 Class II Transseptal Needle, Trocar. RPN TSNC-18-71.0, T... Oct 8, 2021
Z-0223-2022 Class II Transseptal Needle with Catheter. RPN TSN-17-75... Oct 8, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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