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Terminated

smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091

FDA Recall Z-0100-2022 · Posted None

Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeDRO
Date Initiated2020-03-10
Date Terminated2023-09-22
Product Quantity20800 units

Reason for Recall

Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

Firm Action

The firm initiated the recall by letter during the week of 03/10/2020. The notices requested the direct consignee notify their customers and collect the responses. The firm is seeking return of the products.

Root Cause

Component design/selection

Distribution Pattern

Austria, France, Germany, Great Britain, and Saudi Arabia

Official Source

View FDA Recall →

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

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