Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: HARTMANN Disposable Surgical Gown Recall

23 Jul 2012

PAUL HARTMANN (Asia-Pacific Ltd) has initiated a recall concerning certain lots of the HARTMANN Foliodress gown under the following trade names:-

According to PAUL HARTMANN (Asia-Pacific Ltd), a quality inspection revealed the individual occurrence of micro-holes in a number of blisters containing sterile surgical gowns and isolation gowns. The micro-holes are unlikely to be detected through visual inspection. As a result, the sterility of affected products may be compromised. PAUL HARTMANN (Asia-Pacific Ltd) advises users not to use the affected products any longer. Product recall is on-going.

According to PAUL HARTMANN (Asia-Pacific Ltd), the affected products were distributed in Hong Kong.

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 23 July 2012

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