# FDA recall Z-1942-2018

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

## Product

Symmetry Olsen bipolar cord:  (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50  (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10  (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102SPC, QTY 10  (d) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1103, QTY 50  (e) Bipolar Cord, Twin Pin Connector, Angled 45o, 12' (3.6m), REF 40-1104, QTY 10  (f) Bipolar Cord, 28 mm Fixed Pin Connector, REF 40-1105-28, QTY 10  (g) Bipolar Cord, 39 mm Fixed Pin Connector, REF 40-1105-39, QTY 10  (h) Bipolar Cord, 28 mm Fixed Pin Connector, Angled 45o, REF 40-1106-28, QTY 10  (i) Bipolar Cord, Twin Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1113, QTY 10  (j) Bipolar Cord, Wolf to Wolf Kleppinger, 12' (3.6m), REF 40-1114, QTY 10  (k) Bipolar Cord, 28 mm Fixed Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1115-28, QTY 10  (l) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3001R, QTY 10  (m) Integrated 

## 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-1942-2018
- **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-1942-2018

## Citation

> AI Analytics. FDA recall Z-1942-2018. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-1942-2018. Source: US FDA. Licensed CC0.

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