Go Medical Industries Pty., Ltd.: 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 16KPES SIZE:16Fr 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 16KPES Product No: AAM 8016KPES***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.

Recall number

Z-0085-2012

Recalling firm

Go Medical Industries Pty., Ltd.

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 16KPES SIZE:16Fr 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 16KPES Product No: AAM 8016KPES***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.

Status

Terminated

Initiated

2011-09-03

Posted

2011-10-21

Terminated

2012-01-30

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.

Root cause

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

14,700

Distribution

Nationwide distribution.

Lot, serial or model codes

Lot #'s:  9080 9081 9361 9362 9865 9866 9867

510(k) numbers

["K002803"]

PMA numbers

not on file

Product code

FCM

Firm FEI

3002807099

Firm city

Perth

Firm state

Western Australia

Firm country

Australia

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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