FDA Medical Device Recalls (openFDA)
TELEFLEX LLC: Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
- Recall number
- Z-0227-2023
- Recalling firm
- TELEFLEX LLC
- Product
- Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
- Status
- Open, Classified
- Initiated
- 2022-09-20
- Posted
- 2022-11-11
- Terminated
- not on file
- Reason
- Product may not be sterile
- Root cause
- Nonconforming Material/Component
- Action
- Teleflex sent an URGENT MEDICAL DEVICE notice to its consignees on 10/03/2022 by Fed Ex 2nd day. The notice explained the problem and the hazard and requested the following actions be taken: "Action list number 1 Medical facilities 1. We request that you immediately check your inventory for product within the scope of this recall. Users should cease use and distribution of affected product and immediately quarantine the affected product. 2. If you have affected product, mark the applicable checkbox on the Acknowledgement Form (Appendix 1) and contact Teleflex Customer Service at the contact details provided below. Teleflex Customer Service will issue a return goods authorization (RGA) number to you. Write the (RGA) number into the respective field in the Acknowledgement Form (Appendix 1) and promptly return this form by email to Teleflex Customer Service at the contact details provided below. You may then return all product in scope. 3. If you do not have affected product, mark the applicable checkbox on the Acknowledgement Form (Appendix 1) and return the form to Teleflex Customer Service at the contact details provided below. 4. Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product. Action list number 2 Distributors 1. Provide this recall notice to all customers who have received affected product. Each customer is then required to complete the Acknowledgement Form (Appendix 1) and return it to you. 2. We request that you immediately check your inventory for affected product. Cease use and distribution of affected product and immediately quarantine the affected product. You may then return all product in scope. 3. As a distributor, you are then required to confirm to Teleflex that you have completed the field activity outlined in actions 1 and 2 of this Action List Number 2. Upon completion of your actions, please forward the completed Acknowledgement Form (Appendix 1) to Teleflex Customer Service at the conta
- Quantity
- 7200 catheters
- Distribution
- TN, CA, NC, TX, FL, OH, MO, IL, OR
- Lot, serial or model codes
- UDI (01)24026704323245(17)250405(10)74E2200810
- 510(k) numbers
- ["K010420"]
- PMA numbers
- not on file
- Product code
- KOD
- Firm FEI
- 3005747797
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
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
- 2026-10-06
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