Device product

ST. CHRISTOPHER'S SECUREMENT SET

Z-1084-2018

October 23, 2017

Class II

Product summary

Firm: Centurion Medical Products Corporation
Event: Event 79329
Status: Terminated
Classification: Class II
Quantity: N/A
Official record key: device-enforcement:Z-1084-2018

Official wording

Reason: 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.

Code information: CSS685 Lot codes: 2015080390 2015092890 2015113090 2016011890 2016031490 2016042590 2016061390 2016071190 2016082290 2016092690 2016110790 2017011690 2017021390 2017031390 2017032790 2017081890

Distribution pattern: Nationally

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.