Z-2333-2016Class III

SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a...

Name: Z-2333-2016 SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a...
Creator: C.R. Bard, Inc.
Published: 2016-06-29
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2016-06-29 / Terminated / root cause: labeling and UDI

FDA source

C.R. Bard, Inc. began a recall of SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK... on 2016-06-29. FDA classified it as Class III and gives the reason as "Labeling problem". 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-2333-2016
Classification: Class III
Status: Terminated
Initiated: 2016-06-29
Posted: 2016-08-03
Terminated: 2017-12-05
Recalling firm: C.R. Bard Inc
Product: SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
Product code: KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Reason for recall: Labeling problem
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Bard Medical sent an Urgent Medical Device Product Recall letter dated June 29, 2016. The letter identified the product, the problem, and the action to be taken by the customer. The letter requested that customers examine their inventory and quarantine the product. The letter also requested a sub-recall. The letter included a reply form which is to be returned to Bard. Customers were also instructed if product was further distributed they identify customers and notify them at once. Customers with questions should contact the BMD Recall Coordinator at 1-800-793-8110.
Quantity in commerce: 530 units
Distribution: Nationwide Distribution to CA, FL, IL, IA, KY, NC, MN, NC, OR, RI, SD, TX, UT, and WA.
Product codes and lots: Lot Number NGZG1722

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2333-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2333-2016	Class III	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-03

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)