Prelude IDEAL 4F Hydrophilic Sheath Introducer contains incorrect 5F dilators
Merit Medical Systems is recalling Prelude IDEAL 4F Hydrophilic Sheath Introducer units (Lot H3082668) that contain 5F dilators instead of the labeled 4F dilators, which may result in procedure delay.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is a labeling error with no reported illnesses or injuries. The source explicitly states the consequence is procedure delay, not patient harm. Class II classification with a packaging/labeling mismatch and no documented patient safety incidents fits the Moderate category per the rubric.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Prelude IDEAL 4F Hydrophilic Sheath Introducer (REF: PID4F16021PW/D) due to a labeling and packaging discrepancy. Units are labeled as containing 4F dilators but instead contain 5F dilators.
The mislabeled devices were distributed internationally to Japan. The affected lot is H3082668 with an expiration date of November 14, 2024. Use of the incorrect dilator size may result in procedure delay.
Healthcare providers should verify the actual dilator size before use to prevent procedural complications. Facilities with affected units should contact Merit Medical Systems for proper handling instructions.
The recalled product
- Product
- Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 40
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)
- UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24
Distribution
Distribution scope not specified by the agency.
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