Medline procedure kits recalled for surgical mask bioburden contamination risk
Medline procedure kits containing surgical masks are recalled nationwide because included masks failed to meet bioburden testing standards, creating potential infection risk during medical procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. While the failure to meet bioburden standards on surgical masks poses a theoretical infection risk in sterile procedures, the absence of reported harm and Class II classification justify a Moderate severity score.
Plain-English summary
Medline Industries, LP is recalling certain procedure kits distributed nationwide that were manufactured with Procedure Masks with SO SOFT Earloops and SOFT TOUCH II Surgical Masks. Approximately 250 units are affected across three lot numbers: 2024030690, 2024041990, and 2024082390.
The masks included in these kits failed to meet the bioburden testing requirements of EN 14683, a standard for surgical masks. Bioburden refers to the level of microorganisms present on a product; masks that do not meet established standards pose a potential risk of contamination during sterile or semi-sterile medical procedures such as central line dressing changes.
Healthcare facilities and medical providers who received these kits should immediately discontinue use of the affected lot numbers and contact Medline Industries for replacement guidance. No illnesses or injuries related to these products have been reported.
The recalled product
- Product
- Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- bioburden
- infection-risk
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 (4)
- 1) DYNDC3188: UDI/DI 10653160348818 (each) 00653160348811 (case)
- Lot Numbers: 2024030690
- 2024041990
- 2024082390.
Distribution
Distributed nationwide across the United States.
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