FEI 3006852457Initial importer

Tomy International

2021 9TH ST. S.E., Dyersville, IA, US

MDR events2All time

Recalls1All time

Registered products8

Establishment typeComplaintComplaint File Establishment per 21 CFR 820.198

Registered product codes

8 product codes

Recent MDR events

2 on file

Recalls

1 on file

Open, ClassifiedDec 22, 2022
Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. if a compromised product is used by a child with a weakened immune system, an infection or other illness could occur.
View FDA record ↗

Compliance history

Matched by FEI 3006852457.

FDA inspections

0 on file

No inspections on file for this FEI number.

Inspection citations

0 on file

No citations on file for this FEI number.

Compliance actions

0 on file

No warning letters or injunctions on file for this FEI number.

Import refusals

0 on file

No import refusals on file for this FEI number.