Recall Z-1735-2025
Galt Medical Corporation · initiated March 27, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
Reason for recall
Due to a potential open seal in the sterile barrier packaging.
FDA-determined cause: Process control
Action taken
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
Details
- Recall number
- Z-1735-2025
- Initiated
- March 27, 2025
- Posted by FDA
- May 7, 2025
- Product code
- OFL – Percutaneous Sheath Introducer Kit
- 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.
- Recalling firm
- Galt Medical Corporation, Garland, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1731-2025 Class II | GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in…Due to a potential open seal in the sterile barrier packaging . | 03/27/2025Open, Classified |
| Z-1732-2025 Class II | B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41…Due to a potential open seal in the sterile barrier packaging . | 03/27/2025Open, Classified |
| Z-1733-2025 Class II | B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model…Due to a potential open seal in the sterile barrier packaging . | 03/27/2025Open, Classified |
| Z-1734-2025 Class II | GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous…Due to a potential open seal in the sterile barrier packaging. | 03/27/2025Open, Classified |
| Z-1736-2025 Class II | Introducer Needle REF NDL-107-04 These needles are used for the percutaneous…Due to a potential open seal in the sterile barrier packaging. | 03/27/2025Open, Classified |
| Z-1737-2025 Class II | Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15…Due to a potential open seal in the sterile barrier packaging. | 03/27/2025Open, Classified |