PureWick External Catheter Recalled for Latex Labeling Errors
Purewick Corporation is recalling 176,863 units of the PureWick External Catheter for Women because the labeling failed to disclose the presence of dry natural rubber and incorrectly stated the product was latex-free.
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: The recall involves allergen mislabeling (dry natural rubber/latex) on a medical device, which fits the rubric criteria for a High severity score (3) due to the risk of allergic reaction, even though no specific injuries are reported in the text.
Plain-English summary
Purewick Corporation is recalling 176,863 units of the PureWick External Catheter for Women (Item # 625). The recall was initiated because the product labeling did not contain the required phrase "This product contains dry natural rubber" and/or erroneously included the phrase "Latex-free." The white gauze component of the device contains dry natural rubber.
The PureWick External Catheter is a flexible, contoured device positioned between the labia and gluteus muscles to draw urine away from the body. The product was distributed nationwide in the United States.
Consumers who have this product should stop using it and contact Purewick Corporation for further instructions. Individuals with a known latex allergy should be particularly cautious, as the device contains dry natural rubber despite the incorrect labeling.
The recalled product
- Product
- PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw urine away from the body through the Wick to a storage container away from the…
- Manufacturer
- Purewick Corporation
- Affected units
- 176,863
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)
- Item # 625
Distribution
Distributed nationwide across the United States.
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