Rapid Refill Continuous Injection System Recalled for Syringe Loosening Risk
Boston Scientific's Rapid Refill Continuous Injection System (UPN M00566001) is being recalled because the recalled Medline Namic Angiographic Control Syringe may loosen or disconnect from the manifold, potentially causing leakage, inability to aspirate or inject, and procedure delays.
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 recall of a medical device with a significant risk-of-harm profile—the potential for improper drug delivery, fluid leakage, and system failure during medical procedures. Although no specific injuries or illnesses are reported in the source text, the hazard involves loss of control over medication administration in a clinical setting, which presents a serious theoretical risk to patient safety.
Plain-English summary
The Rapid Refill Continuous Injection System, UPN M00566001, manufactured by Boston Scientific Corporation, contains a recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. The syringe may loosen or become completely disconnected from the manifold due to a connection defect.
This defect creates a risk of loose or failed connections, difficulty connecting the syringe, inability to aspirate or inject medication properly, fluid leakage, and potential separation of the syringe from the system. These complications may require device exchange and prolonged procedure time.
The recall affects 153,921 units distributed in the US nationwide, with 119,274 units distributed outside the US. The affected lot numbers are specified in the FDA recall notice Z-2725-2026. Customers and healthcare facilities should stop using the affected devices and contact Boston Scientific Corporation for instructions on returns or replacement.
The recalled product
- Product
- Rapid Refill Continuous Injection System, UPN M00566001
- Manufacturer
- Boston Scientific Corporation
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 (20)
- UDI-DI (GTIN) 08714729285151 Lots 33786611
- 33825949
- 33826026
- 33949916
- 33968571
- 33968575
- 34079981
- 34153104
- 34153413
- 34153415
- 34203075
- 34203077
- 34153411
- 34203079
- 34203115
- 34386605
- 34386609
- 34386613
- 34429656
- 34429658
Distribution
Distributed nationwide across the United States.
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