Z-0119-2025Class II

Medline Heart Cabg Cds, Ref Cds983376r

Name: Z-0119-2025 Medline Heart Cabg Cds, Ref Cds983376r
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-08-28
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-08-28 / Open, Classified / root cause: labeling and UDI

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE HEART CABG CDS, REF CDS983376R on 2024-08-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0119-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-28
Posted: 2024-10-17
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Heart Cabg Cds, Ref Cds983376r
Product code: LRO General Surgery Tray
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 15 kits
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI 40195327548545 (case), 10195327548544 (each), Lot Numbers: 24BMF012, 24CMG491

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0119-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0119-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17
Z-0120-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17
Z-0121-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17
Z-0122-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17
Z-0123-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17
Z-0124-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17

Product code LRO

K213481Class IIMedline General Surgery TrayMedline Industries, Inc. / cleared 2022-05-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)