Recall Z-2154-2014— Teleflex Medical

Name: FDA recall Z-2154-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-10

Class III · Terminated

Class III FDA medical device recall by Teleflex Medical, initiated 2014-07-10, terminated 2015-11-25. It names one FDA 510(k) clearance: K901185. Product: RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.. Reason: 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..

Recalling firm: Teleflex Medical
Classification: Class III
Status: Terminated
Initiated: 2014-07-10
Terminated: 2015-11-25
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K901185 — FOLEY CATHETER INSERTION TRAY (10CC)Orion Life Systems, Inc.·cleared 1990-07-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.