Z-2154-2014Class III

RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical

Name: Z-2154-2014 RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical
Creator: Teleflex Medical
Published: 2014-07-10
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-07-10 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730 on 2014-07-10. FDA classified it as Class III and gives the reason as "Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2154-2014
Classification: Class III
Status: Terminated
Initiated: 2014-07-10
Posted: 2014-08-06
Terminated: 2015-11-25
Recalling firm: Teleflex Medical
Product: RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
Product code: FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Reason for recall: Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified via letter on/about 07/10/2014.
Quantity in commerce: 720
Distribution: Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX.
Product codes and lots: Product Code: 76730, Lot number: 307505.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2154-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2154-2014	Class III	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-06

Product code FCM

K901185Class IIFoley Catheter Insertion Tray (10Cc)Orion Life Systems, Inc. / cleared 1990-07-20

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)