Z-1097-2018Class II
Wound Care Kit
Centurion Medical Products, LP / initiated 2017-10-23 / Terminated / root cause: manufacturing process
Centurion Medical Products Corporation began a recall of WOUND CARE KIT on . FDA classified it as Class II and gives the reason as "Convenience Kit containing components to assist practitioner with IV placement and securement". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1097-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Centurion Medical Products, LP
- Product
- Wound Care Kit
- Product code
- LRP Tray, Surgical
- Reason for recall
- Convenience Kit containing components to assist practitioner with IV placement and securement.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- On October 16, 2017 a PRODUCT CORRECTION letter was issued to customers notifying them that if they had any kits in their inventory, Centurion will supply labels to affix to the front of each kit instructing the user to discard the prep pad upon opening the kit. Other components of the kit may continue to be used and are NOT within the scope of this recall.
- Distribution
- Nationally
- Product codes and lots
- SUT13705 Lot codes: 2016072190
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1078-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1079-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1080-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1081-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1082-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1083-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1084-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1085-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1086-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1087-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1088-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1089-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1090-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1091-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1092-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1093-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1094-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1095-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1096-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1097-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1098-2018 | Class II | Terminated | Voluntary: Firm initiated |
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