Z-0227-2023Class II

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

Name: Z-0227-2023 Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140...
Creator: Teleflex Llc
Published: 2022-09-20
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2022-09-20 / Open, Classified / root cause: manufacturing process

FDA source

TELEFLEX LLC began a recall of Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter on 2022-09-20. FDA classified it as Class II and gives the reason as "Product may not be sterile". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0227-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-20
Posted: 2022-11-11
Recalling firm: Teleflex Medical
Product: Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
Product code: KOD Catheter, Urological
Reason for recall: Product may not be sterile
Root cause tag: manufacturing process
FDA 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 in commerce: 7200 catheters
Distribution: TN, CA, NC, TX, FL, OH, MO, IL, OR
Product codes and lots: UDI (01)24026704323245(17)250405(10)74E2200810

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0227-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0227-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11

Product code KOD

K010420Class IIRusch Mmg/o'neil CatheterRusch, Inc. / cleared 2001-05-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)