FDA recall Z-1089-2018

Product

BLOOD DRAW KIT

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.

Distribution

Nationally

Key facts

Status

Terminated

Initiation date

2017-10-23

Report date

2018-03-28

Termination date

2018-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Williamston, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1089-2018