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Terminated

Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.

FDA Recall Z-0577-2018 · Posted None

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeJOH
Date Initiated2016-07-15
Date Terminated2020-04-24
Product Quantity1

Reason for Recall

Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.

Firm Action

The firm, Smith Medical, notified the consignee by phone on July 29, 2017 of the Field Corrective Action Report. The consignee was instructed to return the devices for destruction and replacement. If you have any questions, contact VP, Global Quality and Regulatory at 219-989-9150.

Root Cause

Under Investigation by firm

Distribution Pattern

International Distribution to:Germany

Official Source

View FDA Recall →

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

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