Medtronic Recalls Laparoscopic Electrode Due to Sterile Barrier Compromise Risk
Medtronic is recalling 3,470 Valleylab Laparoscopic Flat L-Hook Electrodes because the package 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 involves a risk-of-harm product (sterile barrier breach) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic is recalling 3,470 units of the Valleylab Laparoscopic Flat L-Hook Electrode Retractable (Item Code: E2784R28ASP). The recall covers affected lots ranging from 209503X through 60870086X. 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 recall was initiated due to a potential for compromise of the package, which could result in a breach of the sterile barrier. This defect poses a risk that the device may not be sterile when used in surgical procedures.
The affected products were distributed worldwide, including nationwide in the United States and internationally to Australia, Canada, Japan, Korea, Hong Kong, and Thailand. Healthcare facilities and users should stop using the affected devices and contact Medtronic for further instructions or replacement.
The recalled product
- Product
- Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP 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
- 3,470
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: 209503X through 60870086X
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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