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Class 2 Device Recall Vein Irrigation Cannula with blunt tip |
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Date Initiated by Firm |
April 24, 2020 |
Create Date |
June 26, 2020 |
Recall Status1 |
Terminated 3 on February 17, 2022 |
Recall Number |
Z-2464-2020 |
Recall Event ID |
85623 |
510(K)Number |
K900753
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Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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Product |
Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
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Code Information |
LOT 2004300013; 2005500214 |
Recalling Firm/ Manufacturer |
LivaNova USA Inc. 14401 W 65th Way Arvada CO 80004-3503
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For Additional Information Contact |
Enrico Milani 303-4255508
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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.
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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 |
325 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
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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.
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510(K) Database |
510(K)s with Product Code = DWF and Original Applicant = SHILEY, INC.
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