Class 2 Device Recall Teleflex Medical RUSCH

• Date Initiated by Firm: September 20, 2022
• Date Posted: November 11, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0227-2023
• Recall Event ID: 90962
• 510(K)Number: K010420
• Product Classification: Catheter, urological - Product Code KOD
• Product: Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
• Code Information: UDI (01)24026704323245(17)250405(10)74E2200810
• Recalling Firm/ Manufacturer: TELEFLEX LLC; 3015 Carrington Mill Blvd; Morrisville NC 27560-5437
• For Additional Information Contact: Customer Service; 866-396-2111
• Manufacturer Reason for Recall: Product may not be sterile
• FDA Determined 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 in Commerce: 7200 catheters
• Distribution: TN, CA, NC, TX, FL, OH, MO, IL, OR
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KOD