Recall Z-0577-2018 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD, Inc.
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.
| Date | Jul 15, 2016 |
| Status | Terminated |
| Reason | Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization. |
| Root cause | Under Investigation by 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. |
| Quantity | 1 |
| Distribution | International Distribution to:Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.