| Class 2 Device Recall Sterile Disposable Connectors | |
Date Initiated by Firm | April 24, 2020 |
Create Date | June 26, 2020 |
Recall Status1 |
Terminated 3 on February 17, 2022 |
Recall Number | Z-2452-2020 |
Recall Event ID |
85623 |
510(K)Number | K833322 |
Product Classification |
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
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Product | Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283 |
Code Information |
LOT 2003400083 |
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 |
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 | 96 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 = DTL
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