Z-1707-2022 Class II Ongoing
FDA device recall Z-1707-2022 was initiated by Cook Incorporated on Jul 19, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 2407 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 21, 2022
- Initiation Date
- Jul 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2407 units
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.
Distribution Pattern
Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA
Code Information
UDI-DI: (01)00827002096080- Lot Numbers: 14071906, 14091204, 14134663, 14134667, 14134669, 14134670, 14134673, 14134676, 14143872, 14143873, 14160997, 14184102, NS14143735, NS14152903
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1707-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026