Cypress Medical Recalls Powder Free Vinyl Exam Gloves
Cypress Medical Products LLC is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because samples failed release specifications, potentially compromising the barrier against infectious material.
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 a risk-of-harm product (medical exam gloves) where the barrier function may be compromised, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Cypress Medical Products LLC is voluntarily recalling one lot of McKesson Powder Free Vinyl Exam Gloves, Item Nos. 14-116 and 14-118. The recall involves 66 cases of the product, which is distributed nationwide in Alabama, Arkansas, Iowa, Louisiana, Oklahoma, Texas, Utah, and Virginia. The specific lot code is CDZG09-30.
The recall was initiated because a sample of the product from this lot did not meet certain release specifications. As a result, it is possible that certain gloves from this lot may not be of medical exam quality and may not provide an effective barrier to infectious material.
These gloves are intended for use by professional healthcare workers and consumers. The source text does not specify further instructions for consumers or healthcare providers regarding the disposal or return of the affected product.
The recalled product
- Product
- Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers and/or consumers.
- Manufacturer
- Cypress Medical Products LLC
- Category
- Medical Device — Exam Gloves
- Hazard
- Affected units
- 66
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)
- CDZG09-30
Distribution
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