FDA recall Z-1943-2018

Product

Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10 Designed to bring high frequency electrical power from the electrosurgical generator to the active.

Reason for recall

Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

Distribution

Worldwide Distribution

Key facts

Status

Terminated

Initiation date

2018-05-11

Report date

2018-06-06

Termination date

2019-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Louisville, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1943-2018