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Central Line Blood Culture Dra, Ref Dyndh1562 recallZ-0312-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 1, 2023

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

This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 11/01/2023 via email. The notice explained the issue and requested that the destruction of the affected kits. Consignees were also instructed to notify all parties if the kits were transferred.

Recall details

Recall number
Z-0312-2024
Status
Open, Classified
Initiated by the company
Nov 1, 2023
Posted by the FDA
Nov 16, 2023
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1600 kits
Product code
OFF
Distribution
US Nationwide distribution in the state of California.

Product description

CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562

Code information (models, lots, serial numbers)

UDI/DI 40193489402446 (case), 10193489402445 (unit): Lot Numbers: 23DMF156, 23CMH030, 23CMD955

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 93379).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page