Medtronic Valleylab Laparoscopic Electrodes Recalled for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach that could compromise the package integrity.
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, and the hazard is a potential sterile barrier breach without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes (Item Code: E277136) because of a potential compromise of the package that could result in a breach of the sterile barrier. The affected units are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation, and suction via a single handset is desirable.
The recall affects 161,940 units distributed worldwide, including the United States, Australia, Canada, Japan, Korea, Hong Kong, and Thailand. The affected lot range is 210654X through 61380120X.
Healthcare facilities should stop using the affected products and contact Medtronic for further instructions regarding the return or replacement of the devices.
The recalled product
- Product
- Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a sing
- Manufacturer
- Medtronic
- Hazard
- Affected units
- 161,940
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)
- Affected Lot Range: 210654X through 61380120X
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Medtronic 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.
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