Device product

MINI PLASTICS SET

Z-1081-2018

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-1081-2018

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: 75700 Lot codes: 2015102790 2016011590 2016030790 2016050490 2016062390 2016071590 2016081790 2016111890 2017012090 2017020790 2017042090

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.