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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00685-3
Product Name/Description ULTRA Fabric Reinforced Surgical Gown, X- Large; MICROCOOL Breathable Gown, with SECURE-FIT, with Towel, X-Large

ULTRA Fabric Reinforced Surgical Gown
Product Code: 95221
All lot numbers beginning with:
AH9284*** to AH9356***
AH0007*** to AH0356***
AH1008*** to AH1364***
AH2006*** to AH2146***

MICROCOOL Breathable Gown
Product Code: 92321
All lot numbers beginning with: AH9303*** to AH9362***
AH0016*** to AH0356***
AH1020*** to AH1364***
AH2009*** to AH2132***

ARTG: 139475
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 11/07/2012
Responsible Entity Kimberly Clark Aust Pty Ltd
Reason/Issue Investigation identified variability occurring during the gown folding process which increased the thickness or height of the folded gown prior to packaging. The increased height of the folded gowns may cause the package seal to be compromised.
Recall Action Recall
Recall Action Instructions Quarantine and return affected devices to Kimberly Clark.
Contact Information 1800 810 077 - Kimberly Clark