Recall Z-1368-2018— Teleflex Medical Europe Ltd

Name: FDA recall Z-1368-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-15

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical Europe Ltd, initiated 2018-03-15, terminated 2020-10-05. It names one FDA 510(k) clearance: K962472. Product: Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.. Reason: These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions..

Recalling firm: Teleflex Medical Europe Ltd
Classification: Class II
Status: Terminated
Initiated: 2018-03-15
Terminated: 2020-10-05
Firm location: Athlone, Ireland

510(k) clearances named in this recall

1 on FDA's record

K962472 — RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERRusch Intl.·cleared 1996-08-27

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

Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.

Reason for recall

These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

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