Recall Z-1840-2022— Cook Incorporated

Name: FDA recall Z-1840-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-16

Class II · Ongoing

Class II FDA medical device recall by Cook Incorporated, initiated 2022-08-16. It names one FDA 510(k) clearance: K182985. Product: Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866. Reason: Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised..

Recalling firm: Cook Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2022-08-16
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K182985 — Roadrunner PC Wire Guide, Olcott Torque DeviceCook Incorporated·cleared 2019-07-22

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

Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866

Reason for recall

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

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