Z-1358-2015Class II

Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code...

Name: Z-1358-2015 Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code...
Creator: C.R. Bard, Inc.
Published: 2015-01-30
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2015-01-30 / Terminated / root cause: packaging

FDA source

C.R. Bard, Inc. began a recall of Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671 on 2015-01-30. FDA classified it as Class II and gives the reason as "Potential breach of the sterile barrier packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1358-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-30
Posted: 2015-04-01
Terminated: 2016-08-01
Recalling firm: C.R. Bard Inc
Product: Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671
Product code: KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Reason for recall: Potential breach of the sterile barrier packaging.
Root cause tag: packaging
FDA root cause: Unknown/Undetermined by firm
Action: Bard sent an Urgent Medical Device Recall letter on January 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter also requested that a sub-recall should be conducted if the product was further distributed. The letter also included a response form which is to be returned to Bard. This voluntary recall is only for the lots noted above with the affected product catalog number. Notifications of this recall are being sent to all affected accounts of Bard Medical Division, Inc. If you have further distributed this product, you are required to notify your accounts of the voluntary recall. If you have any questions or need assistance in notifying your accounts about the correction, please call 1-770-784-6471. We appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action.
Quantity in commerce: 9,620 units
Distribution: Nationwide Distribution to the states of : AL, AZ, CA, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VA, WV and WA.
Product codes and lots: Lot Numbers NGYJ0603 and NGYJ1671

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1358-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1358-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-04-01

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