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Sklar Instruments recallZ-0935-2025 · Sklar Instruments · initiated Dec 3, 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 Sklar Instruments 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

Reports of various packaging issues that may result in a breach of the sterile barrier.

FDA root cause category: Under Investigation by firm

What the company is doing

On December 3, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Action required: 1. Check your inventory for any affected product lots (see Attachment A). If you have affected product in inventory, discontinue use immediately. 2. Notify Additional Users. If you have further distributed any of the items referenced in this notification, you must notify those downstream customers of this recall. Forward a copy of this letter, along with copies of Attachment A and the Recall Acknowledgement form, for such customers to complete and return to Sklar. 3. Notify Sklar. Please complete the enclosed Recall Acknowledgement form as soon as possible, indicating whether you do or do not have any of the affected products remaining in your inventory and whether you have distributed any of the affected products to downstream customers. Return the form to Sklar by e-mail to [email protected]. 4. Return the affected product. If you do have any of the affected products in inventory, Sklar customer service will contact you to arrange for the affected product to be returned. Sklar will credit its direct customers for returned affected product once it receives the affected product back. Sklar Instruments is committed to providing high quality, safe, and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have experienced an adverse event associated with any of these products, please contact us and/or report the event to FDA s MedWatch Adverse Event Reporting program online.

Recall details

Recall number
Z-0935-2025
Status
Open, Classified
Initiated by the company
Dec 3, 2024
Posted by the FDA
Jan 16, 2025
Recalling firm
Sklar Instruments
Quantity
1050 units
Product code
GDG
Distribution
Domestic: Nationwide Distribution

Product description

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HOOK 2MM STERILE CS/25, Model Number 96-4021M; 3) ECONO STERILE VEIN HOOK 2.5MM STERILE CS/25, Model Number 96-4022M; venous procedures

Code information (models, lots, serial numbers)

1) 96-4020M, UDI/DI 50649111476356, Lot codes: SK-125; 2) 96-4021M, UDI/DI 50649111476363, Lot codes: SK-125, SK-128; 3) 96-4022M, UDI/DI 50649111476370, Lot codes: SK-125.

Devices named in this recall

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

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 95946).

Sources and updates

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