FDA recall Z-1034-2019

Product

PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities.

Reason for recall

Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities

Distribution

US nationwide distribution in the state of OH.

Key facts

Status

Terminated

Initiation date

2019-01-25

Report date

2019-03-27

Termination date

2019-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mortsel, N/A, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1034-2019