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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Category
- Medical Device
- Affected units
- 8
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.
Part of a larger recall action
This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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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