PlainRecalls
FDA Devices Moderate Class II Terminated

3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285

Reported: July 8, 2020 Initiated: April 24, 2020 #Z-2459-2020

Product Description

3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285

Reason for Recall

XXX

Details

Recalling Firm
LivaNova USA Inc.
Units Affected
220 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)
Location
Arvada, CO

Frequently Asked Questions

What product was recalled?
3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285. Recalled by LivaNova USA Inc.. Units affected: 220 units.
Why was this product recalled?
XXX
Which agency issued this recall?
This recall was issued by the FDA Devices on July 8, 2020. Severity: Moderate. Recall number: Z-2459-2020.