Class 2 Device Recall Sierra Scientific Motility Visualization System (MVS)

• Date Initiated by Firm: October 12, 2011
• Date Posted: October 28, 2011
• Recall Status: Terminated on August 30, 2012
• Recall Number: Z-0135-2012
• Recall Event ID: 60175
• 510(K)Number: K031169
• Product Classification: System, gastrointestinal motility (electrical) - Product Code FFX
• Product: AR ManoShield, MSS-3599, 10 pack.; ; FGS: MSS-3599,; Individual package label: LBL-110275-03,; Box label: LBL-110282-03,; Package Inserts: DOC-3682,; User Manual: DOC-1332-12.; ; Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.
• Code Information: F1112702UA, F1113101UA, F1113103UA, F1113104UA, F1113401UA, F1114201UA, F1114617UA, F1114618UA, F1114619UA, F1114620UA, F1114621UA, F1114623UA, F1114624UA, F1114625UA, F1114626UA, F1114627UA, F1114628UA, F1114629UA, F1115402UA, F1116306UA, F1117207UA, F1119201UA, F1119401UA, F1121304UA, F1123201UA, F1123405UA, F1123703UA, F1124202UA, F1124301UA, F1125105UA, F1125201UA, F1127303UA, F1128101UA, F1129701UA, F1130202UA, F1130304UA, F1128301UA, F1127103UA, F1127205UA,
• Recalling Firm/ Manufacturer: Sierra Scientific Instruments Inc; 5757 W Century Blvd Ste 660; Los Angeles CA 90045-6456
• For Additional Information Contact: 310-641-8492
• Manufacturer Reason for Recall: The recall was initiated after Given Imaging received a test report during a Canadian licensing process where the AR ManoShield exhibited pinholes and did not pass the test, the Field Safety Corrective Action (FSCA) Committee was convened. As a result of the data discussed during this meeting, a decision was made to voluntarily recall this product, and cease its further commercialization or distr
• FDA Determined Cause: Nonconforming Material/Component
• Action: Given Imaging sent an "Urgent Product Recall 1st Notice" letter with an attached Device Recall Confirmation Form (via Fed Ex with signature for tracking purposes) to all customers who purchased the AR ManoShield, part numbers MSS-3599. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were instructed to locate the affected product and removed from use immediately. The letter stated that if the affected product have been further distributed, forward this letter immediately to all customers who received the affected product. Customers were asked to complete and return the enclosed confirmation form as per the instructions. Customers with any questions were instructed to contact Karla Guerrero at (310) 641-8492 ext. 2138 or email at karla.guerrero@givenimaging.com.
• Quantity in Commerce: 292 units
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Chile, China, Columbia, Ecuador, France, Germany, Israel, Mexico, Poland, Portugal, Sweden, and Switzerland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FFX and Original Applicant = SIERRA SCIENTIFIC INSTRUMENTS, INC.