Recall Z-0187-2024— MICROVENTION INC.

Name: FDA recall Z-0187-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-24

Class II · Ongoing

Class II FDA medical device recall by MICROVENTION INC., initiated 2023-08-24. It names one FDA 510(k) clearance: K151358. Product: AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324. Reason: Peripheral coil system detachable has a potential of unsealed pouch packaging..

Recalling firm: MICROVENTION INC.
Classification: Class II
Status: Ongoing
Initiated: 2023-08-24
Firm location: Aliso Viejo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K151358 — AZUR CX Detachable 35 CoilsMicroVention, Inc.·cleared 2015-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.