Boston Scientific Peristaltic Tubing Kit, Model 2104, UPN M0043521040. For use with Boston Scientific CHILLI Cooled Abla

FDA device recall Z-0170-2011 · posted 2010-11-01 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

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.

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.

Root cause

Packaging

Status

Terminated

Product code

LPB

Quantity affected

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 countr

Date initiated

2010-09-27

Date posted

2010-11-01

Date terminated

2012-04-17

Location

Maple Grove, MN