FDA recall Z-1841-2019

Product

ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H 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

Reason for recall

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

Distribution

Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada

Key facts

Status

Terminated

Initiation date

2019-04-19

Report date

2019-06-26

Termination date

2021-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1841-2019