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Open, Classified

Sensica Urine Output System

FDA Recall Z-1293-2022 · Posted None

Recalling FirmC.R. Bard Inc
Recall StatusOpen, Classified
Product CodeEXS
Date Initiated2022-05-19
Product Quantity457 units

Reason for Recall

Complaints relating to urine output measurement accuracy.

Firm Action

The firm issued a recall notification via email and Fed Ex on 05/19/2022. The letter instructs the consignee to immediately discontinue use of the system, quarantine and store to prevent usage, share the notice with users of the product, and return the response form.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide.

Official Source

View FDA Recall →

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

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