# FDA recall Z-1943-2018

> **Olsen Medical** · Class II · device recall initiated 2018-05-11.

## 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

- **Recall number:** Z-1943-2018
- **Recalling firm:** Olsen Medical
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1943-2018. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1943-2018. Source: US FDA. Licensed CC0.

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