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Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165 recallZ-0167-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Sep 4, 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

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.

Recall details

Recall number
Z-0167-2025
Status
Open, Classified
Initiated by the company
Sep 4, 2024
Posted by the FDA
Oct 23, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
15 units
Product code
LRP
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Product description

Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit

Code information (models, lots, serial numbers)

UDI/DI 40653160273586 (each), 10653160273585 (case), Lot Numbers: 24ABB506

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 95415).

Sources and updates

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