High FDA (Devices)·Z-0696-2022·Announced 2022-03-09

MEDLINE Micro-Kill Bleach Germicidal Wipes Recall: Out-of-Specification Sodium Hypochlorite

MEDLINE recalls Micro-Kill Bleach Germicidal Wipes due to out-of-specification low levels of sodium hypochlorite, the active disinfecting ingredient. Affected batches may have reduced effectiveness.

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: FDA Class II recall for out-of-specification sodium hypochlorite in a disinfectant product, representing a risk-of-harm scenario. No illnesses or injuries reported, meeting the High severity criterion per FDA standards.

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes due to out-of-specification (low) levels of sodium hypochlorite, the active ingredient responsible for disinfecting and germicidal action. The affected wipes contain sodium hypochlorite at concentrations below the specified level, which may result in reduced disinfecting effectiveness.

Approximately 359,524 units have been distributed worldwide, including throughout the US, Panama, and Bermuda. The recall affects wipes with Model Numbers MSC351400AN, MSC351410AN, and MSC351440AN, with specific lot and batch numbers identified in the recall notice.

Consumers and healthcare facilities using the recalled wipes should discontinue use. Contact MEDLINE INDUSTRIES, LP for information regarding returns, refunds, or replacement products.

The recalled product

Product: MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Disinfectant Wipes
Hazard: insufficient-concentration
reduced-efficacy
Affected units: 359,524

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 (20)

a. Model No.: MSC351400AN
UDI: 10888277652514
20106
20109
20225
20300
and 20301 Lot No.: 306 and Batch ID: 20300
20301
21105
21109
UDI: 10888277652521
Lot No.: 208 and Batch ID: 20079 Lot No.: 209 and Batch ID: 20080
20083
and 20303 Lot No.: 210 and Batch ID: 20083
20084
20085
20093
20097
20100
and 20101 Lot No.: 229 and Batch ID: 20104 Lot No.: 230 and Batch ID: 20101

Distribution

Distributed nationwide across the United States.

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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