FDA recall Z-0187-2024

Product

AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324

Reason for recall

Peripheral coil system detachable has a potential of unsealed pouch packaging.

Distribution

US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.

Key facts

Status

Ongoing

Initiation date

2023-08-24

Report date

2023-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Aliso Viejo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0187-2024