Z-0406-2017Class II

Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014

Name: Z-0406-2017 Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014
Creator: C.R. Bard, Inc.
Published: 2016-10-13
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2016-10-13 / Terminated / root cause: labeling and UDI

FDA source

C.R. Bard, Inc. began a recall of Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014 on 2016-10-13. FDA classified it as Class II and gives the reason as "Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0406-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-13
Posted: 2016-11-14
Terminated: 2022-02-10
Recalling firm: C.R. Bard Inc
Product: Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Product code: FAD Stent, Ureteral
Reason for recall: Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Bard Medical sent an Urgent: Medical Device Communication Letter dated October 13, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action required: Examine your inventory and identify any product subject to this notification. If you have any remaining inventory, include a copy of this communication with the unit(s) for future use. If you may have further distributed or transferred this product, please identify the respective organizations and notify them at once of this communication. Your notification to these organizations may be enhanced by including a copy of this product communication letter. This notification should be carried out to the user level. This product notification is being made with the knowledge of the Food and Drug administration. We appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action. For further questions, please call (770) 784-6220.
Quantity in commerce: 75,089 units
Distribution: U.S. Nationwide.
Product codes and lots: Product Codes: REK32N and FEK32HW.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0406-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0403-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-14
Z-0404-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-14
Z-0405-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-14
Z-0406-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-14

Product code FAD

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)