Z-1943-2018 Class II Terminated
FDA device recall Z-1943-2018 was initiated by Olsen Medical on May 11, 2018 and is designated Class II. Reason for recall: Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. The recall status is terminated (terminated April 15, 2019). Affected quantity: 71,890 devices.
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