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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Peristaltic Tubing Kit, Model 2104

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 Class 2 Recall
Boston Scientific Peristaltic Tubing Kit, Model 2104
see related information
Date Posted November 01, 2010
Recall Status1 Terminated on April 17, 2012
Recall Number Z-0170-2011
Recall Event ID 56909
Premarket Approval
PMA Numbers
P980003 P990054
Product Classification Cardiac Ablation Percutaneous Catheter - Product Code LPB
Product 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.
Code Information Lot: 61035169, 61071543, 61066975, 61066976, 61088879, 61088880, 61088881, 61088882, 61090636
Recalling Firm/
Manufacturer
Boston Scientific Corporation
1 Scimed Pl
Maple Grove, Minnesota 55311-1565
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Bob Ware
510-624-2563
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action 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.
Quantity in Commerce 4031 US , 663 OUS
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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LPB and Applicant = BOSTON SCIENTIFIC
PMAs with Product Code = LPB and Applicant = BOSTON SCIENTIFIC CORP.
PMAs with Product Code = LPB and Applicant = CARDIAC PATHWAYS CORP.
PMAs with Product Code = LPB and Applicant = EP TECHNOLOGIES, INC.
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