Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 50,055 units distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. A sterile barrier breach in a surgical device presents a significant risk of infection or injury.
Plain-English summary
Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrode Retractable units (Item Code E2783R36ASP) because of a potential compromise of the package that could result in a breach of the sterile barrier. The affected lot range is 208908X through 61220113X.
The recall involves 50,055 units that were distributed nationwide in the United States and internationally to Australia, Canada, Japan, Korea, Hong Kong, and Thailand. These devices 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 FDA has classified this recall as Class II. Healthcare providers and facilities should stop using the affected devices and contact Medtronic for further instructions on return or replacement.
The recalled product
- Product
- Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP 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 v
- Manufacturer
- Medtronic
- Affected units
- 50,055
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: 208908X through 61220113X
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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