Recall Z-0227-2023— TELEFLEX LLC

Name: FDA recall Z-0227-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-20

Class II · Ongoing

Class II FDA medical device recall by TELEFLEX LLC, initiated 2022-09-20. It names one FDA 510(k) clearance: K010420. Product: Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.. Reason: Product may not be sterile.

Recalling firm: TELEFLEX LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-09-20
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K010420 — RUSCH MMG/O'NEIL CATHETERRusch, Inc.·cleared 2001-05-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Product may not be sterile

Data sourced from openFDA. This site is unofficial and independent of the FDA.