Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Argon Modified Flat l Electrodes due to a potential sterile barrier breach.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterile barrier breach) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Medtronic is recalling Valleylab Laparoscopic Argon Modified Flat l Electrodes, Item Code E258128, due to a potential for compromise of the package resulting in a breach of the sterile barrier. The affected lot range is 211742X through 60870082X, with a total quantity of 3,530 units.
These electrodes 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 covers units distributed worldwide, including the United States (nationwide) and internationally to Australia, Canada, Japan, Korea, Hong Kong, and Thailand.
The FDA has classified this as a Class II recall. Healthcare facilities should stop using the affected devices and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 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
- Manufacturer
- Medtronic
- Hazard
- Affected units
- 3,530
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: 211742X through 60870082X
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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