Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended

FDA device recall Z-0206-2015 · posted 2014-12-16 · Terminated

Recall details

Recalling firm

Philips Medical Systems, Inc.

Reason for recall

Mold on gel filled Gel-E and Squishon products

Action taken

Philips Healthcare/Children's Medical Ventures issued a Medical Device Recall Letter dated Oct 10, 2014. Customers were asked to discontinue use and dispose of all product in their facility, even if mold is not visible. Following these actions, customers will be asked to return a reply form indicating that these actions have been completed. Customers will be given credit for all disposed products. Further, the Gel-E Donut and Squishon 2 products will be withdrawn from the market. Customers with questions were instructed to contact their Philips/Children's Medical Ventures representative. For questions regarding this recall call 978-687-1501.

Root cause

Material/Component Contamination

Status

Terminated

Product code

FMP

Quantity affected

336,695 units

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to: Canada, Australia, Austria, Belgium, France, Germany, Iceland, Ireland, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Portug

Date initiated

2014-10-10

Date posted

2014-12-16

Date terminated

2016-11-29

Location

Andover, MA