1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278
FDA Recall Z-2458-2020 · Posted None
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Recalling FirmLivaNova USA Inc.
Recall StatusTerminated
Product CodeDTL
Date Initiated2020-04-24
Date Terminated2022-02-17
Product Quantity20 units
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.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
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)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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