Recall Z-1069-2020 ยท LRQ Tracheostomy And Nasal Suctioning Kit
Centurion Medical Products Corporation
Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPOSABLE TRACH TRAY
| Date | Dec 11, 2019 |
| Status | Terminated |
| Reason | Incomplete seals on the sterile package may compromise the sterility |
| Root cause | Packaging process control |
| Action | Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Pleas |
| Distribution | Nationwide Foreign: GHANA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.