Olsen Medical Recalls Bipolar Cords Due to Sterile Seal Risk
Olsen Medical is recalling 323,886 bipolar cords because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential compromise of the sterile seal, which is a significant quality issue but does not explicitly report injuries or hospitalizations, fitting the Moderate criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Olsen Medical is recalling 323,886 units of Symmetry Olsen bipolar cords. The recall covers various models, including those with twin pin connectors, fixed pin connectors, and integrated irrigation tubing sets. These devices are intended for use in coagulating tissue.
The recall was initiated because the products may encroach into the sterile pouch seal, thereby increasing the risk of the seal being compromised. The affected devices were distributed worldwide.
Healthcare facilities and users should stop using the affected devices and contact Olsen Medical for instructions on how to return or replace them.
The recalled product
- 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)
- Manufacturer
- Olsen Medical
- Hazard
- Affected units
- 323,886
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all codes
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Olsen Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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