Z-1082-2018Class II
Circumcision Tray
Centurion Medical Products, LP / initiated 2017-10-23 / Terminated / root cause: manufacturing process
Centurion Medical Products Corporation began a recall of CIRCUMCISION TRAY on . FDA classified it as Class II and gives the reason as "Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1082-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Centurion Medical Products, LP
- Product
- Circumcision Tray
- Product code
- LRP Tray, Surgical
- Reason for recall
- Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 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
- CIT6020 CIT6120 Lot codes: 2015081790 2015112090 2016011190 2016022390 2016031690 2016042690 2016061590 2016080890 2016090690 2016100790 2017010990 2017020990 2017040490 2017051590 2017061690 2015111390 2016012190 2016022390 2016033190 2016060690 2016071890 2016092290 2016111590 2017020990 2017030790 2017041390 2017051590
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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