Recall Z-1707-2022— Cook Incorporated

Name: FDA recall Z-1707-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-19

Class II · Ongoing

Class II FDA medical device recall by Cook Incorporated, initiated 2022-07-19. It names one FDA 510(k) clearance: K182985. Product: Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.. Reason: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised..

Recalling firm: Cook Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2022-07-19
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 Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Reason for recall

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

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