FDA recall Z-2497-2019

Product

CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.

Reason for recall

possibility of the sterility batch being insufficiently sterilized

Distribution

US Nationwide distribution in the state of CA.

Key facts

Status

Terminated

Initiation date

2019-08-07

Report date

2019-09-18

Termination date

2020-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2497-2019