Kerr/Pentron Recalls Glutaraldehyde Solution Due to Labeling Discrepancy
Kerr/Pentron is recalling Regimen 28 Day Glutaraldehyde Solution because the bottle label states a 45-minute immersion time, while the product instructions specify 90 minutes.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling discrepancy regarding immersion time, which fits the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, is recalling Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution. The recall was initiated because the immersion time stated on the bottle is 45 minutes, while the product instructions specify 90 minutes.
The affected product is identified by Part Number 10-6465 (McKesson Reorder # 341). The recall includes specific lot numbers: 16 1250, 16 1274, 16 1324A, 16 1324B, 16 2337, 17 1038, 17 1038A, 17 1083, 17 1193, 17 1262, 17 2122, 17 2142, 17 2219, 17 2306, 17 2347A, 18 1092B, 18 1121, 18 2037, and 18 3164.
The product was distributed in Arizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington. Users should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
- Hazard
- Affected units
- 31,904
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 (19)
- Part Number: 10-6465 (McKesson Reorder # 341) Lot Numbers: 16 1250
- 16 1274
- 16 1324A
- 16 1324B
- 16 2337
- 17 1038
- 17 1038A
- 17 1083
- 17 1193
- 17 1262
- 17 2122
- 17 2142
- 17 2219
- 17 2306
- 17 2347A
- 18 1092B
- 18 1121
- 18 2037
- and 18 3164.
Distribution
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