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Tearaway Introducer Set recallZ-1737-2025 · Galt Medical Corporation · initiated Mar 27, 2025

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 Galt Medical Corporation 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

Due to a potential open seal in the sterile barrier packaging.

FDA root cause category: Process control

What the company is doing

On 03/27/2025, the firm emailed customers an "URGENT: MEDICAL DEVICE RECALL" Letter informing them that affected products may have an open seal in the sterile barrier packaging that will render the product non-sterile and will increase the risk of patient harm due to microbial and environmental contamination. Customers are instructed to: 1.DO NOT USE OR DISTRIBUTE THE DEVICEs LISTED IN THIS RECALL. Identify and segregate the affected lot(s) that are in their possession as well as those in the possession of their end-users. 2. Complete the enclosed Field Correction Reply Forms and email or fax them to the attention of the Corrections Coordinator at [email protected] or 214-778-1433. We have enclosed two forms: one to account for inventory at their facility and the other for capturing these exact details from their end users. The form lists the product number, lot number, and quantity that the firm's records indicate their facility has received. It is essential that, even if they do not have any product remaining in their possession, they complete the attached forms (Attachment A & B), indicating zero quantity to be returned, and email or fax the forms to GALT MEDICAL CORP. 3. Ship the returned product to GALT MEDICAL CORP. using Galt s carrier account information listed on the forms. 4. Reference Return Authorization Number RMA# 1200 on the outside of the shipping box and include a copy of the Field Correction Reply Forms with their shipment. 5. Once the completed Field Correction Reply Forms have been received and processed, Galt will issue a credit to customers for the returned product. Please place a new purchase order (PO), noting Replacement Parts for new products. For questions, contact Quality Director at 1-214-778-1306

Recall details

Recall number
Z-1737-2025
Status
Open, Classified
Initiated by the company
Mar 27, 2025
Posted by the FDA
May 7, 2025
Recalling firm
Galt Medical Corporation
Quantity
490 units
Product code
OFL
Distribution
Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.

Product description

Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

Code information (models, lots, serial numbers)

Catalog Number: KIT-051-01, UDI-DI code: 00841268106130 Lot Numbers: 24298473 24190504 INT-101-15, UDI-DI code: 00841268107380 Lot Number: 24284447

Devices named in this recall

2 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 96622).

Sources and updates

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