| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00773-1 |
| Product Name/Description |
Philips Gel-E Donut and Squishon 2 (Gel filled Pillow)
Part numbers: 92025-A, 92025-B, 92025-C (Gel-E Donut) and 91033-2 (Squishon 2)
ARTG number: 200647 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Philips Healthcare has received a number of complaints about visible mould on Gel-E Donut and Squishon 2 gel-filled products. The mould manifests as small black markings on the outer surface of the Gel-E Donut and Squishon pad, which are visible through the transparent outer packaging. The mould detected on the product has been Cladosporium and Penicillium fungi, which are commonly found moulds. NICU and PICU patients are much more sensitive to moulds and there is potential for the mould to be transferred to these environments once the outer pack is opened. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are advised to review their entire inventory of Gel-E Donut and Squishon 2 products and inspect each product for signs of visible mold. Mold should be readily seen as black dots or splotches through the transparent outer packaging. Please do not open the packaging to do the inspection. If unsure or if the inspection is inconclusive, please err on the side of caution and designate that product as containing mold. Dispose of any product containing mold per facility’s environmental guidelines and return unaffected product to their inventory. Customers are also referred to the Instructions for Use, in particular:
Wipe all Gel product surfaces with an antibacterial agent and cover the Gel product with a disposable cover or soft cloth before patient use. This action has been closed-out on 17/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |