FDA-Device2019-06-26Class II

ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures

Ethicon, Inc.
Hazard

Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

Sold states
Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
Affected count
36 eaches
Manufactured in
Us Highway 22 West, N/A, Somerville, NJ, United States
Products
ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1842-2019

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