medical Class II Updated 2020-07-08

LivaNova USA Inc. recalls 1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/

Recalled Product

1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278

Hazard / Issue

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.

Issued by

FDA

Affected States: 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, WV
Lot/Code Info: LOT 2004900015
View official government recall

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