Boston Scientific Peristaltic Tubing Kit, Model 2104, UPN M0043521040. For use with Boston Scientific CHILLI Cooled Ablation Catheters and Model 8005 Continuous Operation Pump. Sterilized using Ethylene Oxide. Contents: peristaltic pump fluid delivery extension tube set. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA. Tubing Set (model 2104) for use with Boston Scientific Cooled Ablation System.
This recall has been terminated (originally issued November 1, 2010).
- Company
- Boston Scientific Corporation
- Recall Initiated
- September 27, 2010
- Posted
- November 1, 2010
- Terminated
- April 17, 2012
- Recall Number
- Z-0170-2011
- Quantity
- 4031 US , 663 OUS
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Boston Scientific is conducting a Recall on CircuCool Tubing Sets used with the Chilli II Cooled Ablation System because there may be a potential for a sterile barrier breach which could compromise device sterility and potentially the sterile field. Even though there have been no reported complaints.
Distribution
Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV and the countries of France, Germany, Great Britain, Hungary, Israel, Italy, Netherlands, Saudi Arabia, Spain, and Taiwan
Lot / Code Info
Lot: 61035169, 61071543, 61066975, 61066976, 61088879, 61088880, 61088881, 61088882, 61090636
Root Cause
Packaging
Action Taken
Boston Scientific Corporation sent an Urgent Medical Device Recall letter, dated September 27, 2010, to all customers via overnight Federal Express. The letter described the product, the problem, and the action the customer should take. The letter instructed customers to cease distribution of affected devices and remove them from their inventory, segregate in a secure location for return to Boston Scientific. A Reply Verification Tracking Form was to be completed and returned via email or faxed to (510) 624-2475 even if the customer did not have any of the affected product. If affected units were located the customer was to call (510) 624-2563 to obtain a Returned Good Authorization (RGA) Number and return to: Boston Scientific Corporation US Distribution Center Boston Scientific Marina Bay Customer Fulfillment Center 500 Commander Shea Blvd. Quincy, Massachusetts 02171 RGA: _________________ For additional questions call (510) 624-2563.