Recall Z-1736-2025

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