Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/ Catalog No. 10005, UPN/Product No. H965100051, STERILE --- Package/Box Units: Box of 5 eaches --- Made in USA: 2301 Centennial Blvd. Jeffersonville, IN 47130 -- Manufactured for: Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752 --- The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.
Recall
- Recall Number
- Z-0647-2012
- Event Number
- 60775
- Firm
- Navilyst Medical, Inc
- FEI Number
- 3017892510
- Product Code
- FGE
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 4, 2011
- Posted
- January 11, 2012
- Terminated
- January 10, 2012
- Address
- 10 Glens Falls, Technical Park Glens Falls, NY, 12801
Description
Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/ Catalog No. 10005, UPN/Product No. H965100051, STERILE --- Package/Box Units: Box of 5 eaches --- Made in USA: 2301 Centennial Blvd. Jeffersonville, IN 47130 -- Manufactured for: Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752 --- The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.
Navilyst Medical, Inc. determined that the Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated.
The firm, Navilyst Medical, sent an "Urgent Medical Device Recall -Immediate Action Required" letter dated February 4, 2011, via Federal Express to the domestic consignees/customers and one foreign consignee/customer. Consignees/customers were instructed to: (1.) Immediately discontinue use and remove the recalled product from inventory; (2.) Segregate this product in a secure location for return to Navilyst Medical, Inc.; (3.) Immediately forward a copy of the recall notification to ALL sites to which they have distributed affected device (4.) promptly complete and return the Reply Verification Tracking Form (even if you do not have any product to return) via fax to: QA Manager, Navilyst Medical, Inc., 1-800-782-1357; (5.) call Customer Service at 1-800-833-9973 between 8:30.am to 7:00pm EST to obtain RMA number; (6.) package and return the recalled product; and (7.) Physicians were instructed to continue to monitor their patients and evaluate per institutional protocol for biliary catheters. If you have any questions about this recall action, your local Sales Representative is available to assist you or contact QA Manager, Navilyst Medical, Inc., directly at 518-742-4571.
Worldwide distribution: USA (nationwide) including states of: AK, AZ, CA, CO, FL, IL, KS, MI, MO, NC, NJ, NY, OH, OK, PA, PR and country of: South Africa.