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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Disposable Connectors

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  Class 2 Device Recall Sterile Disposable Connectors see related information
Date Initiated by Firm April 24, 2020
Create Date June 26, 2020
Recall Status1 Terminated 3 on February 17, 2022
Recall Number Z-2443-2020
Recall Event ID 85623
510(K)Number K833322  
Product Classification Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
Product Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153
Code Information LOT 2002800185
Recalling Firm/
Manufacturer		 LivaNova USA Inc.
14401 W 65th Way
Arvada CO 80004-3503
For Additional Information Contact Enrico Milani
303-4255508
Manufacturer Reason
for Recall		 The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.
FDA Determined
Cause 2		 Packaging process control
Action The firm sent an URGENT MEDICAL DEVICE REMOVAL letter to affected customers on 04/24/2020. The purpose of this medical device correction is to: 1. Advise the customers of the present issue and not to use the affected devices; 2. Providing information to the user on product disposal or return and replacement; 3. Inform affected customers that LivaNova will coordinate replacement for the unused products.
Quantity in Commerce 120 units
Distribution US - AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV OUS- Spain (Hospital de Barsuto, Bilbao, Spain)
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 = DTL and Original Applicant = GISH BIOMEDICAL, INC.
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