Recalls / —

—#197698

Product

CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760

FDA product code

OXQ — Dressing Change Tray

Device class

Class 1

Medical specialty

General Hospital

Affected lot / code info

UDI/DI 10653160274841, Lot Numbers 22ABO498

Why it was recalled

The kit contained an expired component.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline Industries issued a DEVICE RECALL notice to its consignees on 12/23/2022 by First Class Mail. The notice explained the problem and requested the following: "REQUIRED ACTION: -Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. -If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form. If you have any questions, please contact the Recall Department at 866-359-1704."

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

US Nationwide distribution in the states of NY, IN, FL, NJ, IL.

Timeline

Recall initiated

2022-12-23

Posted by FDA

2023-01-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #197698. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.