Merit Medical Guide Sheath Roadster Recalled for Incorrect Dilator Sizing
Merit Medical is recalling Prelude Guide Sheath Roadster devices because some sheaths labeled as .018 dilators may actually contain .038 dilators, creating a risk of using incorrectly-sized medical devices.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is a sizing mismatch that could affect medical procedure outcomes, but no actual harm has been documented, per rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Merit Medical Systems, Inc. is recalling Prelude Guide Sheath Roadster devices (REF PG6F45S018, 6F 0.087", 45 cm, STERILE EO) due to a labeling defect that could result in the use of incorrectly-sized medical devices during clinical procedures.
Some sheaths labeled with .018 dilators may contain .038 dilators instead. If a physician selects a sheath based on the label and unknowingly uses an incorrectly-sized device, it could affect the outcome of the procedure.
The affected lot is H2817178 (UDI: 00884450770771), with 27 units distributed worldwide to the United States (California statewide distribution), New Zealand, and Canada. Physicians and healthcare facilities should not use sheaths from this lot. Contact Merit Medical Systems, Inc. for return instructions.
The recalled product
- Product
- Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- incorrect-sizing
- mis-labeling
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 (1)
- Lot # H2817178/ UDI: 00884450770771
Distribution
Distributed nationwide across the United States.
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