FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: MEDLINE HEART CABG CDS, REF CDS983376R
- Recall number
- Z-0119-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE HEART CABG CDS, REF CDS983376R
- Status
- Open, Classified
- Initiated
- 2024-08-28
- Posted
- 2024-10-17
- Terminated
- not on file
- Reason
- Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
- Root cause
- Under Investigation by firm
- Action
- Medline issued an UREGENT MEDICAL DEVICE NOTIFICATION to its consignees on 08/28/2024 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the consignee quarantine the product and response to obtain labeling to be placed on the affected inventory. Distributors are directed to notify those to whom they shipped the affected product.
- Quantity
- 15 kits
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI/DI 40195327548545 (case), 10195327548544 (each), Lot Numbers: 24BMF012, 24CMG491
- 510(k) numbers
- ["K213481"]
- PMA numbers
- not on file
- Product code
- LRO
- 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