Ra Medical Systems Recalls DABRA Catheters Due to Calibration Failure Risk
Ra Medical Systems is recalling DABRA catheters because the actual shelf life is shorter than labeled, potentially causing calibration failures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential functional failure (calibration) due to labeling/shelf-life discrepancies, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ra Medical Systems, Inc. is recalling DABRA Catheters (5F, 1.5mm) because the firm identified a potential problem where the product's shelf life is currently less than the labeled shelf life. This discrepancy may result in a higher catheter calibration failure rate.
The recall affects 5,082 units with reference number 1222-5000-01. The affected products have manufacturing dates ranging from September 3, 2018, to August 26, 2019, and expiration dates from September 2019 to August 2020. Specific lot numbers include 18-090400-094 and 19-092400-041.
Distribution was worldwide, including nationwide distribution in the United States across multiple states and internationally in the Netherlands, Pakistan, United Kingdom, Italy, and France. Users should stop using the affected catheters and contact Ra Medical Systems for instructions on return or replacement.
The recalled product
- Product
- Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF:
- Manufacturer
- Ra Medical Systems, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 5,082
Distribution
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