Z-1061-2020Class II
Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSING CHANGE KIT...
Centurion Medical Products, LP / initiated 2019-12-11 / Terminated / root cause: packaging
Centurion Medical Products Corporation began a recall of Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSING CHANGE KIT NICU BSIPICC1003A PICC DRESSING CHANGE KIT 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-1061-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Centurion Medical Products, LP
- Product
- Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSING CHANGE KIT NICU BSIPICC1003A PICC DRESSING CHANGE KIT
- Product code
- OXQ Dressing Change Tray
- 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
- BSICVC1005A CVC DRESSING CHANGE KIT NICU 2018103090 BSIPICC1002A PICC DRESSING CHANGE KIT NICU 2019021390 BSIPICC1003A PICC DRESSING CHANGE KIT 2019041690, 2019030190
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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