Medline procedure kits recalled for surgical masks failing sterilization tests
Medline SHORT TERM INFUSAPORT ACCESS KIT with reorder number DYNDC3188 is recalled because included surgical masks failed bioburden testing, potentially compromising sterility during procedures.
What this means for you
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: FDA Class II medical device recall involving potential bioburden contamination on surgical masks. No illnesses or injuries have been reported. This is a risk-of-harm product where injury has not yet been reported, fitting the rubric criterion for High severity.
Plain-English summary
Medline Industries has recalled 1,450 units of the SHORT TERM INFUSAPORT ACCESS KIT (reorder number DYNDC3188) distributed nationwide in the United States. The recall was initiated because the kits contained Procedure Masks with SO SOFT Earloops and SOFT TOUCH II Surgical Masks that were recalled for failing to meet bioburden testing requirements specified in EN 14683, an international standard for surgical mask performance.
Bioburden testing ensures that surgical masks meet strict microbial contamination limits required for safe use in sterile medical procedures. Masks that fail these requirements may not provide adequate sterility protection, which could affect the safety of infusion port access procedures.
The affected kit is identified by reorder number DYNDC3188, with UDI/DI codes 10653160348825 (each) and 00653160348828 (case). The recalled lot numbers are 2024040390, 2024051490, 2024070590, and 2024100790. Healthcare facilities and providers who received these kits should quarantine them and contact Medline Industries for replacement stock or further instructions.
The recalled product
- Product
- Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,450
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 (5)
- 1) DYNDC3188: UDI/DI 10653160348825 (each) 00653160348828 (case)
- Lot Numbers: 2024040390
- 2024051490
- 2024070590
- 2024100790.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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