FDA recall Z-0411-2022

Product

regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.

Reason for recall

The kit contains a non-sterile needle.

Distribution

Distribution was made to Missouri. There was no foreign/military/government distribution.

Key facts

Status

Terminated

Initiation date

2021-11-04

Report date

2021-12-29

Termination date

2023-08-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Republic, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0411-2022