FDA Medical Device Recalls (openFDA)
Medline Industries Inc: Central Line Dressing Change Tray
- Recall number
- Z-3013-2020
- Recalling firm
- Medline Industries Inc
- Product
- Central Line Dressing Change Tray
- Status
- Terminated
- Initiated
- 2020-08-12
- Posted
- not on file
- Terminated
- 2021-04-28
- Reason
- Potential of incomplete seals impacting the sterility of the kit.
- 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
- 60 kits
- Distribution
- Domestic Distribution: MN and TX.
- Lot, serial or model codes
- Lot Number: 2020021990 Product Numbers: DYNDC1928C
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OXQ
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28