FDA recall Z-2221-2024

Product

Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101

Reason for recall

The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.

Distribution

US Nationwide

Key facts

Status

Ongoing

Initiation date

2024-06-03

Report date

2024-07-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Caledonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2221-2024