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U.S. Department of Health and Human Services

Class 2 Device Recall Rectal Catheters;

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  Class 2 Device Recall Rectal Catheters; see related information
Date Initiated by Firm March 15, 2018
Date Posted April 12, 2018
Recall Status1 Terminated 3 on October 05, 2020
Recall Number Z-1368-2018
Recall Event ID 79579
510(K)Number K962472  
Product Classification Cystometric gas (carbon-dioxide) on hydraulic device - Product Code FAP
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.
Code Information Batch Numbers: 13DE17 13EE22 13FE24 13FE26 13GE28 13GE29 13GE31 13KE47 13LE49 14AE03 14AE04 14FE25 14GE27 14HE32 14HE33 14HE35 14IE37 14IE38 14LE49 15AE05 15BE08 15CE13 15DE15 15DE16 15DE17 15DE18 15FE23 15FE25 15FE26 15GE27 15GE28 15GE29 15GE30 15HE32 
Recalling Firm/
Manufacturer		 Teleflex Medical Europe Ltd
Ida Business Park
Athlone Ireland
Manufacturer 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.
FDA Determined
Cause 2		 Employee error
Action The firm initiated their field correction on 03/15/2018 by letter. The notices stated the following: Affected distributors are instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. Using the provided customer letter template and acknowledgment form, communicate this notification to any of your customers who have received product included within the scope of this notification. 3. Have each of your customers who received the affected product return a completed acknowledgment form to you. 4. Once you have finished collecting and consolidating all of the acknowledgment forms, from your customers and placing a copy of this notification with each unit of affected product in your inventory, please complete the enclosed Distributor Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document completion of this recall. Affected direct customers are instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. Users should note This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Upon finding additional lots, the firm issued additional letter on 06/27/2018 with the same message as the letter disseminated in March.
Quantity in Commerce 6340 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FAP and Original Applicant = RUSCH INTL.
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