Z-3013-2020Class II

Central Line Dressing Change Tray

Name: Z-3013-2020 Central Line Dressing Change Tray
Creator: Medline Industries Inc
Published: 2020-08-12
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-08-12 / Terminated / root cause: sterility

FDA source

Medline Industries Inc began a recall of Central Line Dressing Change Tray on 2020-08-12. FDA classified it as Class II and gives the reason as "Potential of incomplete seals impacting the sterility of the kit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-3013-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-12
Posted: 2020-09-24
Terminated: 2021-04-28
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Central Line Dressing Change Tray
Product code: OXQ Dressing Change Tray
Reason for recall: Potential of incomplete seals impacting the sterility of the kit.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 60 kits
Distribution: Domestic Distribution: MN and TX.
Product codes and lots: Lot Number: 2020021990 Product Numbers: DYNDC1928C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3013-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3013-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-24

Product code OXQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)