Recalls / —
—#161230
Product
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 product code
- JOH — Tube Tracheostomy And Tube Cuff
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- Affected lot / code info
- GS025081
Why it was recalled
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Smiths Medical ASD, Inc.
- Address
- 5700 W 23rd Ave, Gary, Indiana 46406-2617
Distribution
- Distribution pattern
- International Distribution to:Germany
Timeline
- Recall initiated
- 2016-07-15
- Terminated
- 2020-04-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #161230. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.