Recall Z-0925-2011 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cook Endoscopy
DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105 This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.
| Date | Jan 19, 2011 (initiated Dec 23, 2010) |
| Status | Terminated |
| Reason | Product defect; There is a risk of gastrointestinal perforation due to balloon deflation difficulty or air embolism resulting in poor patient outcomes including death. |
| Root cause | Other |
| Action | The firm, Cook Medical, sent an "URGENT: PRODUCT RECALL" letter dated January 7, 2011, to all customers. The letter described the product, problem and the actions to be taken by the customers. The customers were instructed to quarantine any affected product and return to Cook Medical. If they are distributors, they were instructed to contact their customers, direct them to quarantine any affected product and coordinate the return of the affected product to Cook Medical. The customers were also instructed to complete and return the bottom of the letter and send to Cook Medical as well as the P |
| Quantity | 103 units (total for both units under recall) |
| Distribution | Worldwide distribution: USA including states of: AL, CA, FL, IL, IN, LA, MA, NC, NY, OH, PA, SC, TN, TX, WA, and WI; and countries of: Belgium, Canada, Germany, Hong Kong, and the Netherlands.. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101095 | DIRECT PERORAL CHOLANGIOSCOPY BALLOON Wilson-Cook Medical, Inc., Jul 19, 2010 |