FDA recall Z-2081-2021

Mckesson Medical-Surgical Inc. Corporate Office · Class II · device

Product

ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the COVID-19 vaccine

Reason for recall

Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some Moderna 140 Ancillary Convenience Kits.

Distribution

US Nationwide Distribution

Key facts

Status: Terminated
Initiation date: 2021-06-02
Report date: 2021-07-28
Termination date: 2022-04-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2081-2021