The Recall Desk
HighFDA (Devices)·Z-1608-2022·Announced 2022-08-31

3M Grounding Safety Ring Pads Recalled Due to Temperature Exposure

3M Grounding Safety Ring pads may have been exposed to excessive temperatures during storage, potentially compromising product effectiveness. The recall affects products distributed nationwide that were received between June and September 2021.

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: This is a Class II medical device recall for a safety-critical grounding product with no reported illnesses or injuries. Per the rubric, a risk-of-harm product where injury has not yet been reported scores 3. While the hazard remains theoretical (temperature may have impacted effectiveness), a compromised grounding device poses potential electrical safety risk.

Plain-English summary

3M Grounding Safety Ring pads (Model 9165) distributed by Mckesson Medical-Surgical Inc. are being recalled. A facility temperature excursion from June through August 2021 prior to delivery may have compromised the product's effectiveness.

The recall applies to all lots received between June 1, 2021, and September 30, 2021. A total of 8 cases were distributed nationwide in the United States. Product identification: GTIN 50707387462593 and 00707387462598 EA.

The recalled product

Product
3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
  • thermal-damage
  • device-malfunction

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 (2)

  • GTIN: 50707387462593
  • 00707387462598 EA

Distribution

Distributed nationwide across the United States.