Z-1370-2018Class II

Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520

Name: Z-1370-2018 Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
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 Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520 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-1370-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-15
Posted: 2018-04-12
Terminated: 2020-10-05
Recalling firm: Teleflex Medical
Product: Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
Product code: KNT Tubes, Gastrointestinal (And Accessories)
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: 200 units
Distribution: US Nationwide Distribution
Product codes and lots: (a) 655300160 655316 Batch Numbers 13EG28 13HG23 (b) 655500200 655520 Batch Numbers: 13EG28

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1370-2018
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 KNT

K841035Class IIUltra Baker Jejunostomy TubeInmed Corp. / cleared 1984-04-13

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)