Medical Action Industries Recalls Dialysis Change Tray Kits Due to Seal Defect
Medical Action Industries is recalling 3,740 Dialysis Change Tray Clear Sequence kits because the needle-free access device may have an improper seal.
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 medical device defect that may compromise the integrity of the seal, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medical Action Industries, Inc. is recalling 3,740 kits (180 cases) of the Dialysis Change Tray Clear Sequence, model number 78791. The recall covers specific lot numbers and is distributed nationwide in the state of California.
The recall is being issued because the convenience kits contain a needle-free access device with an improper seal. This defect may result in doming or tearing of the silicone seal.
Consumers who have these specific kits should stop using them and contact Medical Action Industries for instructions on how to return the product.
The recalled product
- Product
- Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
- Manufacturer
- Medical Action Industries, Inc. 306
Distribution
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