Recall Z-1717-2022— Cook Incorporated

Name: FDA recall Z-1717-2022
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: K110009. Product: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. 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

K110009 — ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDECook, Inc.·cleared 2011-02-02

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 UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. 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.