Z-0967-2017Class II

SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device

Name: Z-0967-2017 SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
Creator: C.R. Bard, Inc.
Published: 2016-07-11
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2016-07-11 / Terminated / root cause: labeling and UDI

FDA source

C.R. Bard, Inc. began a recall of SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device on 2016-07-11. FDA classified it as Class II and gives the reason as "The product contained a latex catheter instead of a silicone catheter". 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-0967-2017
Classification: Class II
Status: Terminated
Initiated: 2016-07-11
Posted: 2017-01-09
Terminated: 2021-10-05
Recalling firm: C.R. Bard Inc
Product: SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
Product code: KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Reason for recall: The product contained a latex catheter instead of a silicone catheter.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Bard Medical sent an Urgent : Medical Device Product Recall Letter dated July 11, 2016, to all affected customers. The letter requested that they check inventory and quarantine product, and if the product had been further distributed, they need to conduct a sub-recall. The letter included a reply form to be returned. For further questions, please call (770) 784-6220.
Quantity in commerce: 2690 units
Distribution: US Distribution to the states of : CA, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, NE, NV, NJ, NM, NY, OR, SC, TN, TX, UT, VA, WA
Product codes and lots: NGAQ4149

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0967-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0967-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09

Product code KNX

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)