Z-0568-2021Class II

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

Name: Z-0568-2021 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga...
Creator: Galt Medical Corporation
Published: 2020-11-16
License: https://open.fda.gov/license/

Galt Medical Corp / initiated 2020-11-16 / Terminated / root cause: manufacturing process

FDA source

Galt Medical Corporation began a recall of Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16 on 2020-11-16. FDA classified it as Class II and gives the reason as "Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0568-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-16
Posted: 2020-12-14
Terminated: 2022-11-07
Recalling firm: Galt Medical Corp
Product: Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Product code: KGZ Accessories, Catheter
Reason for recall: Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0568-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0568-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-14

Product code KGZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)