Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or

FDA device recall Z-2192-2014 · posted 2014-08-20 · Terminated

Recall details

Recalling firm

Childrens Medical Ventures

Reason for recall

The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.

Action taken

Childrens Medical Ventures sent an Urgent Medical Device Recall letter dated May 28, 2014, to affected customers via UPS. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to review entire inventory and inspect for signs of visible mold, do not open the packaging to do the inspection, the mold should be seen through the transparent outer packing, complete and return the reply form provided on the last page of the letter, dispose of any product containing mold per your facilitys environmental guidelines, do not return any product to your Distributor or to Philips/Childrens Medical Ventures.and credit for disposed product will be given. If you need any further information or support concerning this problem, please contact your Distributor at the following phone number:

Root cause

Material/Component Contamination

Status

Terminated

Product code

FMP

Quantity affected

332,649

Distribution

Worldwide Distribution - USA (nationwide) including the country of Canada.

Date initiated

2014-05-28

Date posted

2014-08-20

Date terminated

2016-11-29

Location

Monroeville, PA