Medline Recalls Central Line Dressing Change Trays Due to Seal Defects
Medline Industries is recalling Central Line Dressing Change Trays because incomplete seals may compromise sterility. The recall affects kits distributed in Minnesota and Texas.
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 a risk of harm (loss of sterility) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Medline Industries Inc is recalling Central Line Dressing Change Trays (Product Number DYNDC1928C, Lot Number 2020021990). The recall was initiated because the kits have a potential for incomplete seals, which may impact the sterility of the product.
The affected product consists of 60 kits per unit. Distribution was limited to domestic locations in Minnesota (MN) and Texas (TX). This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and consumers who have purchased these specific kits should stop using them and contact Medline Industries for instructions on return or replacement. The recall number is Z-3013-2020.
The recalled product
- Product
- Central Line Dressing Change Tray
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 60
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: 2020021990 Product Numbers: DYNDC1928C
Distribution
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