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.
This recall has been terminated (originally issued July 15, 2016).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- July 15, 2016
- Terminated
- April 24, 2020
- Recall Number
- Z-0577-2018
- Quantity
- 1
- Firm Location
- Gary, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Distribution
International Distribution to:Germany
Lot / Code Info
GS025081
Root Cause
Under Investigation by firm
Action Taken
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.
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