Z-1368-2018Class II

Rectal Catheters; Product Code Equivalent Code 580114 580114

Name: Z-1368-2018 Rectal Catheters; Product Code Equivalent Code 580114 580114
Creator: Teleflex Medical Europe Ltd
Published: 2018-03-15
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2018-03-15 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical Europe Ltd began a recall of Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal... on 2018-03-15. FDA classified it as Class II and gives the reason as "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". 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-1368-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-15
Posted: 2018-04-12
Terminated: 2020-10-05
Recalling firm: Teleflex Medical
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.
Product code: FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. 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 [email protected]. 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1368-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1367-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-07-05
Z-1368-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-07-05
Z-1369-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-07-05
Z-1370-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-07-05

Product code FAP

K962472Class IIRusch Urodynamic Rectal Balloon 2-Way CatheterRusch Intl. / cleared 1996-08-27

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)