O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL ST

FDA device recall Z-0088-2012 · posted 2011-10-21 · Terminated

Recall details

Recalling firm

Go Medical Industries Pty., Ltd.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FCM

Quantity affected

2100 kits

Distribution

Nationwide distribution.

Date initiated

2011-09-03

Date posted

2011-10-21

Date terminated

2012-01-30

Location

Perth, Western Australia, Australia

Related 510(k) clearances