FDAClass IIIMarch 27, 2019

PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film recall

PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating…

Why was PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

REF CODE/ BATCH XJUB8 36930048; XJM73 36930048; XJUDD 36930047; XJUDD 36940001; XJM85 36940001; XJUDD 36940002; EKLYZ 36940003.

Product
PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating…
Recalling firm
Agfa N.V.
Quantity
2029 boxes
Distribution
US nationwide distribution in the state of OH.
Recall date
March 27, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls