Vascular Solutions Recalls Twin-Pass RX Dual Access Catheters Due to Manufacturing Defect
Vascular Solutions is recalling Twin-Pass RX Dual Access Catheters because excess manufacturing material may remain at the tip or within the distal lumen.
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 potential for excess material to remain in the device, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Vascular Solutions, Inc. is recalling the Twin-Pass RX Dual Access Catheter, model 5210, lot number 577762. The recall involves 11,670 units that were distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international markets.
The recall is being conducted because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature.
Healthcare providers and facilities should stop using the affected devices and contact Vascular Solutions for further instructions regarding the recall.
The recalled product
- Product
- Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consist
- Manufacturer
- Vascular Solutions, Inc.
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 11,670
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model 5210
- Lot number: 577762
Distribution
Part of a larger recall action
This product is one of 3 recalled by Vascular Solutions, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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