Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0-35 G01844 : DTVN-5.0-19-10.0- YUEH : G09490
Reported: April 24, 2024 Initiated: March 1, 2024 #Z-1528-2024
Product Description
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0-35 G01844 : DTVN-5.0-19-10.0- YUEH : G09490
Reason for Recall
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Details
- Recalling Firm
- Cook Incorporated
- Units Affected
- 55 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0-35 G01844 : DTVN-5.0-19-10.0- YUEH : G09490. Recalled by Cook Incorporated. Units affected: 55 units.
Why was this product recalled? ▼
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2024. Severity: Moderate. Recall number: Z-1528-2024.
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