—#196306

Product

Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.

FDA product code: KOD — Catheter, Urological
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K010420
Affected lot / code info: UDI (01)24026704323245(17)250405(10)74E2200810

Why it was recalled

Product may not be sterile

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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

Recalling firm

Firm: TELEFLEX LLC
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: TN, CA, NC, TX, FL, OH, MO, IL, OR

Timeline

Recall initiated: 2022-09-20
Posted by FDA: 2022-11-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196306. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.