Z-1069-2020Class II
Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370...
Centurion Medical Products, LP / initiated 2019-12-11 / Terminated / root cause: packaging
Centurion Medical Products Corporation began a recall of Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPOSABLE TRACH TRAY on . FDA classified it as Class II and gives the reason as "Incomplete seals on the sterile package may compromise the sterility". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1069-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Centurion Medical Products, LP
- Product
- Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPOSABLE TRACH TRAY
- Product code
- LRQ Tracheostomy And Nasal Suctioning Kit
- Reason for recall
- Incomplete seals on the sterile package may compromise the sterility
- Root cause tag
- packaging
- FDA 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. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122.
- Distribution
- Nationwide Foreign: GHANA
- Product codes and lots
- TC6282G TRACHEOSTOMY CARE TRAY 2019013190 TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY 2018101690 TC7370 TRACHEOSTOMY KIT 2018121790 TC7450 DISPOSABLE TRACH TRAY 2019011690
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1042-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1043-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1044-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1045-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1046-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1047-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1048-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1049-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1050-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1051-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1052-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1053-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1054-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1055-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1056-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1057-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1058-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1059-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1060-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1061-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1062-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1063-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1064-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1065-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1066-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1067-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1068-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1069-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1070-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1071-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1072-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1073-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1074-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1075-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1076-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1077-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1078-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1079-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1080-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1081-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1082-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1083-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1084-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1085-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1086-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1087-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1088-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1089-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1090-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1091-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1092-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1093-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1094-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1095-2020 | Class II | Terminated | Voluntary: Firm initiated |
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.