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Recall Observatory FDA recall evidence

Device product

Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252

Z-2448-2020

April 24, 2020

Class II

Product summary

Firm
LivaNova USA Inc.
Event
Event 85623
Status
Terminated
Classification
Class II
Quantity
72 units
Official record key
device-enforcement:Z-2448-2020

Official wording

Reason: 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.

Code information: LOT 2002800189

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)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.