Recalls / —

—#183395

Product

Central Line Dressing Change Tray

FDA product code

OXQ — Dressing Change Tray

Device class

Class 1

Medical specialty

General Hospital

Affected lot / code info

Lot Number: 2020021990 Product Numbers: DYNDC1928C

Why it was recalled

Potential of incomplete seals impacting the sterility of the kit.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On August 26th 2020 the firm sent an Urgent Recall letter to its consignees with the following information: This letter is to inform you that Medline Industries, Inc. is recalling our Central Line Dressing Change Tray DYNDC1928C and lot number 2020021990 due to the potential of incomplete seals impacting the sterility of the kit. REQUIRED ACTION: 1. Immediately check your stock for item number DYNDC1928C and the affected lot number, 2020021990. 2. Please destroy affected product, and complete the enclosed destruction form listing the quantity destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. Credit will be issued for recalled products, upon receipt of your completed destruction form. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. All affected product should be destroyed. If you have any questions, please contact 866-359-1704.

Recalling firm

Firm

Medline Industries Inc

Address

Three Lakes Drive, Northfield, Illinois 60093

Distribution

Distribution pattern

Domestic Distribution: MN and TX.

Timeline

Recall initiated

2020-08-12

Terminated

2021-04-28

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #183395. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.