Merit Medical Prelude Introducer Sheath Recalled for Incorrect Dilator
Merit Medical is recalling 373 Prelude Short Sheath Introducer units from lot H2069291 due to potential incorrect dilators in some packages. The defect could affect device functionality in clinical procedures.
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 3/5 (High).
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 involving a manufacturing defect with no reported illnesses or injuries and theoretical hazard. Per the rubric, this constitutes a 'risk-of-harm product where injury has not yet been reported,' warranting a High severity score.
Plain-English summary
Merit Medical Systems, Inc. is recalling Prelude Short Sheath Introducer units (model REF: PSS-6F-4-018MT, lot H2069291) due to a manufacturing defect in which packages may contain an incorrect dilator component.
The recall affects 373 units distributed worldwide, including to healthcare facilities across US states (Idaho, Hawaii, Texas, California, Arizona, Minnesota, Utah, Kansas, Missouri) and internationally (Republic of Korea, Netherlands, Germany, Cyprus, Italy, Sweden, Taiwan, Spain).
An incorrect dilator could impact the device's intended function and safe use in vascular procedures. No illnesses or injuries have been reported. Healthcare facilities should verify lot numbers and contact Merit Medical Systems, Inc. if affected product is in their inventory.
The recalled product
- Product
- MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 373
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 # H2069291
Distribution
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