Recall Z-2611-2016
Cook Inc. · initiated April 15, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
Codes / lots: All Lots. Catalog prefixes HNR5.0 Catalog/product number; Global/order number HNR5.0-35-100-P-10S-0 G09697 HNR5.0-35-100-P-10S-CFP G11264 HNR5.0-35-100-P-10S-PIG G09059 HNR5.0-35-100-P-8S-VCF G31403 HNR5.0-35-100-P-NS-0 G10313 HNR5.0-35-100-ST-10S-0 G09565 HNR5.0-35-100-ST-10S-PIG G09525 HNR5.0-35-110-P-10S-0 G11241 HNR5.0-35-110-P-10S-PIG G11265 HNR5.0-35-65-P-8S-VCF G12129 HNR5.0-35-70-P-10S-0 G09411 HNR5.0-35-70-P-10S-CFP G11262 HNR5.0-35-70-P-10S-PIG G08832 HNR5.0-35-70-P-10S-PIG-RICKETTS-081983 G11280 HNR5.0-35-70-P-4S-PED G11281 HNR5.0-35-70-P-NS-0 G11959 HNR5.0-35-70-ST-10S-0 G09564 HNR5.0-35-70-ST-10S-PIG G09050 HNR5.0-35-80-P-8S-NEFF-CANADA-082098 G11860 HNR5.0-35-90-P-10S-0 G09412 HNR5.0-35-90-P-10S-CFP G11266 HNR5.0-35-90-P-10S-PIG G09408 HNR5.0-35-90-P-10S-PIG-RICKETTS-081983 G11282 HNR5.0-35-90-P-6S-PED G11729 HNR5.0-35-90-P-8S-VCF G12799 HNR5.0-35-90-ST-10S-0 G11641 HNR5.0-35-90-ST-10S-PIG G09197 HNR5.0-38-100-P-10S-0 G11267 HNR5.0-38-100-P-10S-CFP G11268 HNR5.0-38-100-P-10S-PIG G09285 HNR5.0-38-100-P-NS-0 G27874 HNR5.0-38-110-P-10S-0 G09461 HNR5.0-38-110-P-10S-PIG G11269 HNR5.0-38-70-P-10S-0 G11270 HNR5.0-38-70-P-10S-CFP G11271 HNR5.0-38-70-P-10S-PIG G11272…
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.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
Cook Inc. sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter dated April 15, 2016, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with any medical questions or concerns, were instructed to contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. For information regarding the recall, please contact Stericycle Expert Solutions at 866.201.9067.
Details
- Recall number
- Z-2611-2016
- Initiated
- April 15, 2016
- Posted by FDA
- August 22, 2016
- Terminated
- August 4, 2017
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Quantity
- 532,395
- 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…
- Recalling firm
- Cook Inc., Bloomington, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2610-2016 Class II | Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, DiagnosticIncrease in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | 04/15/2016Terminated |
| Z-2612-2016 Class II | Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | 04/15/2016Terminated |
| Z-2613-2016 Class II | Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | 04/15/2016Terminated |
| Z-2614-2016 Class II | Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | 04/15/2016Terminated |
| Z-2615-2016 Class II | FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | 04/15/2016Terminated |
| Z-2616-2016 Class II | Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | 04/15/2016Terminated |
| Z-2617-2016 Class II | Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | 04/15/2016Terminated |
| Z-2618-2016 Class II | Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | 04/15/2016Terminated |
| Z-2619-2016 Class II | Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | 04/15/2016Terminated |
| Z-2620-2016 Class II | Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | 04/15/2016Terminated |
| Z-2621-2016 Class II | Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | 04/15/2016Terminated |
| Z-2622-2016 Class II | Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | 04/15/2016Terminated |
| Z-2623-2016 Class II | White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | 04/15/2016Terminated |