Z-1065-2020Class II
Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAINAGE TRAY...
Centurion Medical Products, LP / initiated 2019-12-11 / Terminated / root cause: packaging
Centurion Medical Products Corporation began a recall of Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAINAGE TRAY ID1670 I&D TRAY ID1715 INCISION & DRAINAGE 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-1065-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Centurion Medical Products, LP
- Product
- Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAINAGE TRAY ID1670 I&D TRAY ID1715 INCISION & DRAINAGE TRAY ID1765 ER I&D PACK ID1765 ER I&D PACK ID1835 I & D TRAY ID2075 I&D TRAY ID585 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY
- Product code
- LRP Tray, Surgical
- 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
- Lot Numbers: ID1235A ESKENAZI INCISION & DRAINAGE TRAY 2019020890 ID1525 INCISION & DRAINAGE TRAY 2019052890 ID1670 I&D TRAY 2019050890 ID1715 INCISION & DRAINAGE TRAY 2018121390 ID1765 ER I&D PACK 2019042290 ID1765 ER I&D PACK 2019021190 ID1835 I & D TRAY 2019041290 ID2075 I&D TRAY 2019052990 ID585 INCISION & DRAINAGE TRAY 2019022090 ID875 INCISION & DRAINAGE TRAY 2019020590 ID875 INCISION & DRAINAGE TRAY 2019011790
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 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.