—#212022

Product

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

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K213481
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 11/18/2024 via USPS and email. The notice explained the reason for the recall and requested quarantine of affected products pending correction. The firm requested the completion of the response form, which upon receipt, Medline will send labels to affix to the affected products with the instructions for the consignee to remove the affected component prior to using the kit.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-11-18
Posted by FDA: 2025-01-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.