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Centurion Medical Products, Silver Antimicrobial Vad Drive… recallZ-1015-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Dec 23, 2022

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

The kit contained an expired component.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline Industries issued a DEVICE RECALL notice to its consignees on 12/23/2022 by First Class Mail. The notice explained the problem and requested the following: "REQUIRED ACTION: -Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. -If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form. If you have any questions, please contact the Recall Department at 866-359-1704."

Recall details

Recall number
Z-1015-2023
Status
Open, Classified
Initiated by the company
Dec 23, 2022
Posted by the FDA
Jan 25, 2023
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1050 kits
Product code
OXQ
Distribution
US Nationwide distribution in the states of NY, IN, FL, NJ, IL.

Product description

CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760

Code information (models, lots, serial numbers)

UDI/DI 10653160274841, Lot Numbers 22ABO498

Devices named in this recall

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

Sources and updates

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