Z-1040-2025 Class II Ongoing
FDA device recall Z-1040-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on November 18, 2024 and is designated Class II. Reason for recall: 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 testi… The recall status is ongoing. Affected quantity: 749 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2025
- Initiation Date
- November 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 749 units
Product Description
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
1) CVI5130: UDI/DI 10653160372349 (each) 00653160372342 (case), Lot Numbers: 2024040490, 2024073190, 2024082790, 2024101790,; 2) STCVC01USGV: UDI/DI 10653160376965 (each) 00653160376968 (case), Lot Numbers: 2024050990.