Vortex Surgical Inc.: Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25

Hazard

Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.

Details from the source

Reason for recall: Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots. Distribution: Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea Quantity: 800 devices Lot/code info: UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020

UPC codes

00810123481132

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.