Peel-Away Introducer medical devices recalled for low packaging seal strength
Cook Incorporated is recalling 55 Peel-Away Introducers due to packaging with low seal strength that may compromise device sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a potential for device sterility compromise. No illnesses, injuries, or deaths are reported in the source material. Per the severity rubric, risk-of-harm products where injury has not yet been reported merit a High (3) classification.
Plain-English summary
Cook Incorporated is recalling Peel-Away Introducer medical devices intended for percutaneous introduction of catheters into blood vessels and nonvascular use.
The packaging may have low seal strength and may not meet peel strength specifications. This defect could compromise the device's sterility.
Approximately 55 units were distributed worldwide, including throughout the United States and to Austria, Australia, Brazil, Canada, Switzerland, Germany, Spain, the United Kingdom, Hong Kong, Ireland, Israel, India, Italy, New Zealand, and Singapore.
The recalled product
- Product
- 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
- Manufacturer
- Cook Incorporated
- Hazard
- sterility-compromise
- packaging-defect
Distribution
Distributed nationwide across the United States.
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