Cardinal Health Recalls Non-Sterilized Curity All Purpose Sponges
Cardinal Health is recalling Curity All Purpose Sponges because they were not sterilized. The affected units were distributed in the US, Canada, and Colombia.
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 is classified as FDA Class II. The hazard involves the use of non-sterilized medical sponges, which presents a risk of infection or adverse health consequences, but the source text does not report specific injuries or fatalities.
Plain-English summary
Cardinal Health 200, LLC is recalling Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (Product Code: 8044). The recall was initiated because the sponges were not sterilized before distribution. The affected lot number is 18E190262, with an expiration date of 05/2023.
The recall involves 10,400 units (13 cases, 800 units per case). These products were distributed worldwide, including the United States, Canada, and Colombia. The sponges are described as a rayon/polyester blend construction, highly absorbent, and ideal for applying ointments, prepping, wiping needles, and cleaning slides.
Consumers and healthcare facilities should stop using the affected sponges and contact Cardinal Health for further instructions. The FDA has classified this recall as Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointments, prepping, wiping needles, cleaning slides and more Rayon/polyester blend construction Highly absorbent.
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
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 Number: 18E190262 Expiration Date: 05/2023
Distribution
Distributed nationwide across the United States.
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