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Terminated

SWIN 2017 database, Model YSW4000

FDA Recall Z-1939-2020 · Posted None

Recalling FirmRemel Inc.
Recall StatusTerminated
Product CodeLON
Date Initiated2019-01-04
Date Terminated2020-08-17
Product Quantity250

Reason for Recall

Potential for out of range microbial results

Firm Action

Technicians replaced YSW514-17 with YSW514-17A.

Root Cause

Software design

Distribution Pattern

...

Official Source

View FDA Recall →

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

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