Z-1943-2018 Class II Terminated

Recalled by Olsen Medical — Louisville, KY

Recall Details

Product Type
Devices
Report Date
June 6, 2018
Initiation Date
May 11, 2018
Termination Date
April 15, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
71,890 devices

Product Description

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 Pattern

Worldwide Distribution

Code Information

all codes