Z-1871-2017Class II

SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile

Name: Z-1871-2017 SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile
Creator: C.R. Bard, Inc.
Published: 2017-03-09
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2017-03-09 / Completed / root cause: labeling and UDI

FDA source

C.R. Bard, Inc. began a recall of SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile on 2017-03-09. FDA classified it as Class II and gives the reason as "Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1871-2017
Classification: Class II
Status: Completed
Initiated: 2017-03-09
Posted: 2017-04-20
Recalling firm: C.R. Bard Inc
Product: SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
Product code: EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Reason for recall: Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Consignees were notified by letter on/about 03/09/2017.
Quantity in commerce: 5030 units
Distribution: CA, CO, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, NE, NJ, NM, OH, OR, PA, RI, TN, TX, VA and WA.
Product codes and lots: Product Code: A300316A, Lot number: NGAV2400

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1871-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1871-2017	Class II	Completed	Voluntary: Firm initiated	2017-04-26	2017-04-20

Product code EYZ

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)