Recall Z-1718-2022 — Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
U.S. FDA — Device Enforcement · United States · 2022-07-19 · Class II
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Reported risk: 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.
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