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U.S. Department of Health and Human Services

Class 2 Device Recall O'Neil Sterile Field Intermittent Urinary Catheter Kit

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  Class 2 Device Recall O'Neil Sterile Field Intermittent Urinary Catheter Kit see related information
Date Initiated by Firm September 03, 2011
Date Posted October 21, 2011
Recall Status1 Terminated 3 on January 30, 2012
Recall Number Z-0084-2012
Recall Event ID 59892
510(K)Number K002803  
Product Classification Tray, catheterization, sterile urethral, with or without catheter - Product Code FCM
Product 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.
Code Information 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.   
Recalling Firm/
Manufacturer		 Go Medical Industries Pty., Ltd.
200 Churchill Avenue
Subiaco
Perth, Western Australia Australia
For Additional Information Contact Jerry Doane
716-775-0533
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 203,743 (189,043 English; 14,700 Spanish)
Distribution Nationwide distribution.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FCM and Original Applicant = GO MEDICAL INDUSTRIES PTY. LTD.
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