Recall Z-1240-2022— Cook Incorporated

Name: FDA recall Z-1240-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-05

Class II · Ongoing

Class II FDA medical device recall by Cook Incorporated, initiated 2022-05-05. It names one FDA 510(k) clearance: K160219. Product: Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498). Reason: The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula..

Recalling firm: Cook Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2022-05-05
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K160219 — Hilal Embolization MicroCoilsCook Incorporated·cleared 2016-08-03

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

Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)

Reason for recall

The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

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