Arrow Percutaneous Sheath Introducer Kits Recalled for Dilator Tip Damage
Arrow International Inc is recalling specific Percutaneous Sheath Introducer Kits due to dilator tip damage that could cause vessel injury.
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: The recall involves a medical device with a defect that poses a risk of harm (vessel damage), but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Arrow International Inc is recalling 15,424 units of Arrow Percutaneous Sheath Introducer Kits. These medical devices are used to permit venous or arterial access and introduce devices to the central circulation.
The recall was initiated because dilator tip damage was noted during internal inspection. This defect has the potential to result in vessel damage during use.
The affected products were distributed nationwide in the United States and in Canada. Specific product codes and lot numbers are listed in the official recall documentation. Healthcare providers and consumers should stop using the affected kits and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 15,424
Distribution
Distributed nationwide across the United States.
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