3M Universal Electrosurgical Pad, with Cord (Catalog Number 9135), 3M Universal Electrosurgical Pad, Split with Cord (C)

• • Ongoing Z-3017-2024 FDA Class II ·initiated 8 Apr 2024

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

• • Ongoing Z-1608-2022 FDA Class II ·initiated 25 May 2022

  Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

• • Terminated Z-0701-2017 FDA Class II ·initiated 26 Oct 2016

  3M is recalling Universal Electrosurgical Pads because a report of an unintended material (process liner) in the product. This may prevent or impede the safe return of electrosurgical current following Electrosurgical Unit (ESU) activation. This defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body.

510(k) Number

K974279 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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