FDA Medical Device Recalls (openFDA)
Teleflex Medical Europe Ltd: Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
- Recall number
- Z-1370-2018
- Recalling firm
- Teleflex Medical Europe Ltd
- Product
- Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
- Status
- Terminated
- Initiated
- 2018-03-15
- Posted
- 2018-04-12
- Terminated
- 2020-10-05
- 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.
- 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 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
- 200 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- (a) 655300160 655316 Batch Numbers 13EG28 13HG23 (b) 655500200 655520 Batch Numbers: 13EG28
- 510(k) numbers
- K841035
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 3007134520
- Firm city
- Athlone
- Firm state
- not on file
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28