Galt Medical Corporation: Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16

Recall number

Z-0568-2021

Recalling firm

Galt Medical Corporation

Product

Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16

Status

Terminated

Initiated

2020-11-16

Posted

2020-12-14

Terminated

2022-11-07

Reason

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

Root cause

Process control

Action

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

Quantity

9,920 catheters (updated on 03/17/2021)

Distribution

U.S.: FL, GA, MA, NC, NJ, OH, PA, Puerto Rico and UT. O.U.S: Canada, Netherlands, Turkey, United Kingdom, and UAE

Lot, serial or model codes

Catalog Number: DRC-002-06  Lot Numbers/UDI Code: 20108509/(01)0084 1268 100398(17)240428(10)20108509 20139676/(01)0084 1268 100398(11)200520(17)240519(10)20139676 20148911/(01)0084 1268 100398(11)200609(17)240608(10)20148911 20160253/(01)0084 1268 100398(11)200707(17)240706(10)20160253 20189100/(01)0084 1268 100398(11)200821(17)240820(10)20189100  Updated Information provided 03/16/2021: For Catalog Number: DRC-002-06 additional Lot Numbers: -20080351 -20234573 -20297230 -21008452  Additional Products: Catalog Number: DRC-006-16 Lot Numbers: -20217235 -20217236 -20217237

510(k) numbers

not on file

PMA numbers

not on file

Product code

KGZ

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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