FDA recall Z-2740-2018

Product

Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.

Reason for recall

Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.

Distribution

Distribution to US states of CA, IL, MD, MN, NJ, OH & PA; and Israel

Key facts

Status

Terminated

Initiation date

2018-06-18

Report date

2018-08-15

Termination date

2019-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2740-2018