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Medline Sterile Iris Scissors Cvd/Std, Ref Dynj04049 recallZ-2595-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Aug 3, 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

4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline Industries issued a recall notice to its consignees by email on 08/03/2023. The notice explained the problem with the device, the potential hazard, and requested the following: Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. Distributors or those who resold or transferred the product were directed to notify their customers and have them destroy any affected product. If you have any questions, please contact the Recall Department at 866-359-1704.

Recall details

Recall number
Z-2595-2023
Status
Open, Classified
Initiated by the company
Aug 3, 2023
Posted by the FDA
Sep 18, 2023
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
324,451 devices
Product code
JOK
Distribution
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Hong Kong, Taiwan, Singapore

Product description

MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049

Code information (models, lots, serial numbers)

UDI/DI 10080196847273, all lots

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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