Device product

NEONATAL IV ACCESS SET

Z-1090-2018

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-1090-2018

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: IV4690 Lot codes: 2015111690 2016012590 2016040490 2016082990 2016111490 2017010990 2017013090 2017052990 2017080790

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.