Events

Recall of O'Neil Sterile Field Intermittent Urinary Catheter Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Go Medical Industries Pty., Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59892
  • Event Risk Class
    Class 2
  • Event Number
    Z-0084-2012
  • Event Initiated Date
    2011-09-03
  • Event Date Posted
    2011-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103942
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tray, catheterization, sterile urethral, with or without catheter - Product Code FCM
  • Reason
    O'neil sterile field intermittent urinary catheter kits with povidone iodine swabsticks are being recalled due to a recall on the triad povidone iodine swabsticks contained within the kit. h&p; industries are recalling the triad povidone iodine swabsticks because it was determined that the swabsticks were manufactured without having a system for microbial testing in place at the time of release.
  • Action
    The firm, Go Medical Industries Pty Ltd, sent an e-mail on September 3, 2011 and follow-up with an "URGENT: MEDICAL DEVICE RECALL" letter dated September 07, 2011 to its customers. The letter described the product, problem and action to be taken. The customers were instructed to quarantine and not sell the product in the market place; immediately perform a sub-recall and notify their customers and complete and return the RETURN RESPONSE FORM via fax at 716-883-8099 or mail to: American Australian Medical Inc, 1083 Delaware Avenue, Buffalo, NY 14209. For further details you can contact QA Manager at Go Medical Industries at +61 89 381 3226 or pmoretta@gomedical.com.au.

Device

O'Neil Sterile Field Intermittent Urinary Catheter Kit
  • Model / Serial
    Lot #s w/English Labeling: 8295 8296 8297 8298 8832 8833 8834 8835 8854 8855 8856 8857 8927 8928 8929 8930 8931 8932 8933 8934 8940 8941 8942 8943 8944 8945 8946 9022 9023 9024 9025 9072 9073 9074 9075 9076 9077 9078 9079 9082 9083 9084 9085 9086 9087 9122 9123 9124 9125 9126 9127 9128 9129 9130 9131 9132 9133 9134 9135 9136 9137 9208 9209 9210 9211 9212 9213 9214 9215 9235 9236 9237 9238 9239 9240 9241 9242 9295 9296 9297 9298 9299 9300 9301 9302 9356 9357 9358 9547 9548.   Lot #'s w/Spanish Labeling: 9750 9751 9754 9755 10000 10001 10002.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 14KPES SIZE:14Fr Product No: AAM 8014KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" || Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 14KPES Product No: AAM 8014KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD || 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: gomedic@linet.net.au Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" || This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.
  • Manufacturer
    Go Medical Industries Pty., Ltd.

Manufacturer

Go Medical Industries Pty., Ltd.
  • Manufacturer Address
    Go Medical Industries Pty., Ltd., 200 Churchill Avenue, Subiaco, Perth, Western Australia Australia
  • Manufacturer Parent Company (2017)
    Go Medical Industries Pty. Ltd.
  • Source
    USFDA