Device product
Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
Z-1041-2025
Product summary
- Event
- Event 96110
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1450 units
- Official record key
device-enforcement:Z-1041-2025
Official wording
Reason: Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
Code information: 1) DYNDC3188: UDI/DI 10653160348825 (each) 00653160348828 (case), Lot Numbers: 2024040390, 2024051490, 2024070590, 2024100790.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.