Recall Z-0568-2021

Reason for recall

Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.

FDA-determined cause: Process control

Action taken

On 11/16/2020, the firm sent an "URGENT-Medical Recall Notice" to customers to inform them that certain Lots of catheters may have a tip geometry with a thicker wall, resulting in a more obtuse tip angle. This obtuse tip angle, if present in the catheter tip, can cause increased insertion resistance through the epidermis layer of the skin. The Recalling Firm is instructing customers to: Note- An updated Customer Notification Letter was sent on 11/20/2020 via email. 1. 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 Corrections Coordinator at quality@galtmedical.com or 214-778-1433. The Recalling Firm has enclosed one form to account for inventory at the customer's facility and an additional form for capturing the same details from their end-users. The form lists the product number, lot number and quantity that the customer has received. The Recalling Firm is pointing out that It is important that even if a customer does not have any product remaining in their possession that they fill out the attached forms (Attachment A & B) noting zero quantity to be returned and email or fax the forms to the Recalling Firm. 3. Ship the returned product to GALT MEDICAL CORP. using Galts carrier account information listed on the forms. 4. Reference Return Authorization Number RMA# GALT_2004 on the outside of the shipping box and include a copy of the Field Correction Reply Forms with your shipment. 5. Once the completed Field Correction Reply Forms have been received and processed, the Recalling Firm will issue a credit to the customer for the product returned. Customer are asked to place a new PO notating Replacement Parts for new products. The cause of the problem has been identified and corrective actions have been implemented to assure this problem does not reoccur. If you h