Medical Action Industries Recalls Urine Clean Catch Kits Due to Labeling Error
Medical Action Industries is recalling Urinary Clean Catch kits due to an internal data-entry error that resulted in an incorrect expiration date on the label.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a data-entry error resulting in an incorrect expiration date on the label. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medical Action Industries, Inc. is recalling 4,000 units of the Urinary Clean Catch kit (Catalog Number 76769, Lot Number 333606). The recall was initiated because an internal data-entry error caused the product to be labeled with an expiration date of March 31, 2027, instead of the correct date of February 28, 2027.
The affected products were distributed in California. The source text does not report any illnesses, injuries, or deaths associated with this recall. Consumers and healthcare facilities should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software Version: N/A
- Manufacturer
- Medical Action Industries, Inc. 306
- Category
- Medical Device — Diagnostic Kits
- Hazard
- Affected units
- 4,000
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 (1)
- Lot Code: Lot Number: 333606 UDI: 20809160118228 Expiration Date: 3/31/2027
Distribution
Distributed in 1 state:
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