Device product

MINOR DRESSING CHANGE TRAY

Z-1087-2018

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-1087-2018

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: DT875 Lot codes: 2015102090 2015120290 2016012190 2016032290 2016052690 2016072890 2016090590 2017010490 2017020790 2017032190 2017042790

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.