Medical Sponges Recalled for Temperature Exposure During Storage
Mckesson Medical-Surgical is recalling MetriSponge cleaning sponges due to facility temperature excursions that may have compromised product effectiveness during storage and delivery between June and August 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: FDA Class II medical device where temperature exposure may have compromised effectiveness. The source does not report illnesses or injuries; the hazard is theoretical. By the rubric, theoretical hazards without reported injury in risk-of-harm products score at most High (3). A medical cleaning device used in healthcare settings constitutes a risk-of-harm product.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling MetriSponge METRIZYME sponges (Model 10-4025) due to facility temperature excursions that occurred between June and August 2021. Exposure to higher temperatures may have impacted product effectiveness.
All affected products were received between June 1, 2021 and September 30, 2021. The recalled products were distributed nationwide. The recall involves 5 boxes of the sponges.
Customers and healthcare facilities should verify whether they have received affected product and consider replacing the sponges to ensure proper cleaning effectiveness.
The recalled product
- Product
- METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 5
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: 00615375006771
- 00615375003671
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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