| 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 |
|
| 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 |