Reported Mar 27, 2019 · Terminated

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

Agfa N.V.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Agfa N.V. · Septestraat 27 · Mortsel, N/A · N/A

Is this the product you have?

  • PET Plates Coated Film-MONOMEDBV2S2-
  • Radiographic Film REF
    • XJUB8
    • XJM73
    • XJUDD
    • XJM85
    • EKLYZ
  • Product UsageDue 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
Lot codes and dates
    • REF CODE/ BATCH XJUB8 36930048
    • XJM73 36930048
    • XJUDD 36930047
    • XJUDD 36940001
    • XJM85 36940001
    • XJUDD 36940002
    • EKLYZ 36940003
Amount recalled
2029 boxes

Where it was sold

  • Nationwide
  • OH

Why it was 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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 14, 2019 · Data as of Sep 19, 5:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.