Galt Medical Corporation: Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.

Recall number

Z-1735-2025

Recalling firm

Galt Medical Corporation

Product

Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.

Status

Open, Classified

Initiated

2025-03-27

Posted

2025-05-07

Terminated

not on file

Reason

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

Root cause

Process control

Action

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 quality@galtmedical.com 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

Quantity

4,280 kits

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.

Lot, serial or model codes

Catalog Number: KIT-002-28 UDI-DI code: 00841268104730 Lot Number: G25038156 KIT-002-34, UDI-DI code: 00841268104792 Lot Number: G25064259 KIT-002-35, UDI-DI code: 00841268104808 Lot Number: G25029077 KIT-011-40, UDI-DI code: 00841268105553 Lot Number: S25031227 KIT-011-62, UDI-DI code: 00841268105614 Lot Numbers: G25052163 G25080165 KIT-038-04, UDI-DI code: 00841268104556 Lot Number: G25092186 KIT-039-03, UDI-DI code: 00841268104587 Lot Numbers: G25050190 G25078192 KIT-039-13, UDI-DI code: 00841268106055 Lot Number: G25050202 KIT-081-02 / PS2-38, UDI-DI code: 00841268108394 Lot Number: G25056231

510(k) numbers

not on file

PMA numbers

not on file

Product code

OFL

Firm FEI

3000718472

Firm city

Garland

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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