CLASS III Device recall · Reported 13 Aug 2014 · FDA Enforcement Report

Rusch Foley Urinary Catheter Insertion Tray recalled by Teleflex Medical

Teleflex Medical is recalling Rusch Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, distributed nationwide in the US. The recall was initiated on 10 Jul 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesProduct Code: 76730, Lot number: 307505.

Quantity recalled720

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2154-2014
FDA event ID: 68746
Recalling firm: Teleflex Medical, Durham, NC
Classification: Class III
Status: Terminated
Recall initiated: 10 Jul 2014
FDA classified: 6 Aug 2014
Reported: 13 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

10 Jul 2014	Recall initiated by company
6 Aug 2014	Classified by FDA	+27 days
13 Aug 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.

Where it was distributed

Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX.

Nationwide California Connecticut Florida Massachusetts Missouri New Jersey Ohio Oregon Texas

Questions about this recall

Is Rusch Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile recalled?

Yes. Teleflex Medical recalled Rusch Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile on 10 Jul 2014. The recall is Class III and its status is Terminated. Recall number Z-2154-2014.

Why was it recalled?

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.

Which lots are affected?

Product Code: 76730, Lot number: 307505.

Where was it sold?

Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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