The Recall Desk
HighFDA (Devices)·Z-2572-2016·Announced 2016-08-24

Medtronic Recalls Laparoscopic Electrodes Due to Sterile Barrier Compromise

Medtronic is recalling 1,440 Valleylab Laparoscopic Wire J-Hook 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 involves a potential breach of the sterile barrier for a surgical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Medtronic is recalling 1,440 units of the Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM (Item Code: E2782R28ASP). The recall affects lot numbers ranging from 213559X through 60520066X. 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. The affected units 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. The U.S. Food and Drug Administration has classified this as a Class II recall.

The recalled product

Product
Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E2782R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and sucti
Manufacturer
Medtronic
Affected units
1,440

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: 213559X through 60520066X

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.

See all 25 products in this recall →