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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Cook Incorporated: 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.

Agency Publication Date: September 9, 2022
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Affected Products

Product: Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

UDI-DI: (01)00827002079373- Lot Numbers: 14145420, 14145424, 14156909, 14156912, 14156916, 14164348, 14173577

Lot Numbers:
Numbers
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.

UDI-DI: (01)00827002096080- Lot Numbers: 14071906, 14091204, 14134663, 14134667, 14134669, 14134670, 14134673, 14134676, 14143872, 14143873, 14160997, 14184102, NS14143735, NS14152903

Lot Numbers:
Numbers
Product: Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

UDI-DI: (01)00827002075160- Lot Numbers: 14103953, 14103956, 14143728, 14145412, 14145419, 14153927, 14156907, 14156908, 14156914, 14160996

Lot Numbers:
Numbers
Product: Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

UDI-DI: (01)00827002075184 Lot Numbers: 14063361, 14087089, 14087092, 14117033, 14120926, 14120928, 14151216, 14151218, 14153159, 14158614, 14159695, 14159696

Lot Numbers:
Numbers
Product: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

UDI-DI: (01)00827002561496- Lot Numbers: 14070921, 14108915, 14108916, 14129152, 14141997, 14170230

Lot Numbers:
Numbers
Product: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

UDI-DI: (01)00827002561618- Lot Numbers: 14095646, 14174879

Lot Numbers:
Numbers
Product: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

UDI-DI: (01)00827002561625- Lot Numbers: 14070920, 14174878

Lot Numbers:
Numbers
Product: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

UDI-DI: (01)00827002561731- Lot Numbers: 14070910, 14070913, 14070914, 14070915, 14070916, 14070917, 14080810, 14104898, 14104899, 14104902, 14106628, 14106629, 14120473, 14120474, 14120475, 14122089, 14122091, 14122093, 14122095, 14122322, 14129155, 14129156, 14129157, 14129158, 14129161, 14129162, 14129163, 14131012, 14131013, 14131014, 14134680, 14134681, 14134683, 14134684, 14139356, 14142001, 14142004, 14142005, 14142007, 14147337, 14147338, 14147339, 14148371, 14160531, 14160533, 14160534, NS14095649, NS14122100, NS14122327, NS14129168, NS14131010, NS14131011, NS14131015, NS14133505, NS14142008, NS14147334, NS14147335, NS14147336, NS14147336X, NS14153793, NS14176970

Lot Numbers:
Numbers
Product: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

UDI-DI: (01)00827002561724- Lot Numbers: 14156569

Lot Numbers:
Numbers
Product: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

UDI-DI: (01)00827002561762- Lot Numbers: 14112845, NS14062106, NS14080814, NS14089120, NS14118843, NS14139358, NS14142006, NS14144747, NS14148490, NS14149799, NS14153797, NS14172915

Lot Numbers:
Numbers
Product: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

UDI-DI: (01)00827002561755- Lot Numbers: 14174876, 14174880, NS14104906, NS14173970, NS14173971

Lot Numbers:
Numbers
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.

UDI-DI: (01)00827002561526- Lot Numbers: 14118842

Lot Numbers:
Numbers
Product: 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.

UDI-DI: (01)00827002561519- Lot Numbers: 14156572

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90710
Status: Active
Manufacturer: Cook Incorporated
Manufactured In: United States
Units Affected: 13 products (496 units; 2407 units; 1450 units; 1997 units; 585 units; 85 units; 35 units; 5400 units; 75 units; 865 units; 189 units; 30 units; 15 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.