Z-1084-2018Class II
St. Christopher's Securement Set
Centurion Medical Products, LP / initiated 2017-10-23 / Terminated / root cause: manufacturing process
Centurion Medical Products Corporation began a recall of ST. CHRISTOPHER'S SECUREMENT SET 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-1084-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Centurion Medical Products, LP
- Product
- St. Christopher's Securement Set
- 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
- CSS685 Lot codes: 2015080390 2015092890 2015113090 2016011890 2016031490 2016042590 2016061390 2016071190 2016082290 2016092690 2016110790 2017011690 2017021390 2017031390 2017032790 2017081890
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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