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Medline Heart Cabg Cds, Ref Cds983376r recallZ-0119-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Aug 28, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0119-2025
Status
Open, Classified
Initiated by the company
Aug 28, 2024
Posted by the FDA
Oct 17, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
15 kits
Product code
LRO
FDA submissions
K213481
Distribution
US Nationwide distribution.

Product description

MEDLINE HEART CABG CDS, REF CDS983376R

Code information (models, lots, serial numbers)

UDI/DI 40195327548545 (case), 10195327548544 (each), Lot Numbers: 24BMF012, 24CMG491

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

321 devices cleared under K213481 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95393).

Sources and updates

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