Recall Z-2946-2020 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD Inc.
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
| Date | Aug 28, 2020 |
| Status | Terminated |
| Reason | Label has the incorrect size for the tracheotomy tube. |
| Root cause | Error in labeling |
| Action | On 08/28/20, the firm, Smiths Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" to its consignees. The consignee was instructed to follow: INSTRUCTIONS TO CUSTOMERS: 1. Locate and quarantine the affected Bivona Mid-Range Aire-Cuf Tracheostomy Tubes in your possession by referring to the attached Urgent Medical Device Recall Response Form. This form identifies the one (1) specific lot number and quantity distributed to your facility. ONLY UNUSED PRODUCT SHOULD BE QUARANTINED FOR RETURN. 2. Complete the attached Urgent Medical Device Recall Form within 10 days of receipt and return it to f |
| Quantity | 3 units |
| Distribution | US Distribution to state of: CT |
| FDA record | Open on fda.gov |