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.
Reported: September 21, 2022 Initiated: July 19, 2022 #Z-1713-2022
Product Description
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.
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.
Details
- Recalling Firm
- Cook Incorporated
- Units Affected
- 5400 units
- Distribution
- 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
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cook Incorporated. Units affected: 5400 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2022. Severity: Moderate. Recall number: Z-1713-2022.
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