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LivaNova USA Inc. Recall: Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/

LivaNova USA Inc. Recall: Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: LivaNova USA Inc.; Product: Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351; Reason

Recalling firmLivaNova USA Inc.
ProductSterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
Reason for recallThe 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionUS - 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)
Recall initiated20200424
Recall numberZ-2456-2020
Categorydevice
StateCO
CountryUnited States

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