Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk
Medtronic is recalling Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
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. The hazard involves a potential breach of the sterile barrier, which is a risk-of-harm scenario for a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic is recalling Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes (Item Code: E25306). The recall involves 19,200 units distributed worldwide, including the United States, Australia, Canada, Japan, Korea, Hong Kong, and Thailand. The affected lot range is 210286X through 61220102X.
The recall was initiated due to a potential compromise of the package that could result in a breach of the sterile barrier. This defect poses a risk of contamination to the medical device before it is used in surgical procedures.
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. Users should stop using the affected devices and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item Code: E25306 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
- Manufacturer
- Medtronic
- Affected units
- 19,200
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: 210286X through 61220102X
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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