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Terminated

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.

FDA Recall Z-1034-2019 · Posted None

Recalling FirmAgfa N.V.
Recall StatusTerminated
Product CodeIWZ
Date Initiated2019-01-25
Date Terminated2019-06-14
Product Quantity2029 boxes

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

Firm Action

Agfa issued Medical Device Recall letter by email dated 1/28/19 stating the problem, action to be taken, health risk and to block the material to prevent distribution.

Root Cause

Mixed-up of materials/components

Distribution Pattern

US nationwide distribution in the state of OH.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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