Recall Z-0202-2022— MICROVENTION INC.

Name: FDA recall Z-0202-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-20

Class II · Terminated

Class II FDA medical device recall by MICROVENTION INC., initiated 2021-10-20, terminated 2024-05-15. It names one FDA 510(k) clearance: K994253. Product: Aspiration Syringe Kit, REF: MVSK60. Reason: Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers..

Recalling firm: MICROVENTION INC.
Classification: Class II
Status: Terminated
Initiated: 2021-10-20
Terminated: 2024-05-15
Firm location: Aliso Viejo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K994253 — VACLOK SYRINGEMerit Medical Systems, Inc.·cleared 2000-01-05

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

Aspiration Syringe Kit, REF: MVSK60

Reason for recall

Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.

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