Recall Z-2622-2016
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
Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system
Codes / lots: All Lots. Catalog/product number; Global/order number BBFS-100 G26088
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-2622-2016
- Initiated
- April 15, 2016
- Posted by FDA
- August 22, 2016
- Terminated
- August 4, 2017
- Product code
- FCL – Forceps, Biopsy, Non-Electric
- Quantity
- 2,606
- 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-2611-2016 Class II | Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The…Increase 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-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 |