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Gel-E Donut and Squishon 2 (2014-05-28)
- Starting date:
- May 28, 2014
- Posting date:
- June 18, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40133
Recalled Products
A) Gel-E Donut
B) Squishon 2
Reason
Philips has become aware that mold has been found on some gel-e donut and Squishon 2 gel-filled products. The mold 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 mold detected ONT EH product has been Cladosporium spp. and Penicillium spp., which are commonly found molds.
Affected products
A) Gel-E Donut
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
92025-A
92025-B
92025-C
Companies
- Manufacturer
-
Children's Medical Ventures, LLC,
191 Wyngate drive
Monroeville
15146
Pennsylvania
UNITED STATES
B) Squishon 2
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
91033-2
Companies
- Manufacturer
-
Children's Medical Ventures, LLC,
191 Wyngate drive
Monroeville
15146
Pennsylvania
UNITED STATES