Acclarent Recalls Expired RELIEVA FLEX Sinus Guide Catheter Units
Acclarent, Inc. is recalling 986 RELIEVA FLEX Sinus Guide Catheter units distributed in Texas because one unit was found to be past its expiry date.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a documentation/expiry date error rather than a functional defect or contamination.
Plain-English summary
Acclarent, Inc. is recalling 986 units of the RELIEVA FLEX Sinus Guide Catheter F-70 (Catalog number GC070RF). The affected units are identified by Lot 120709i-cm and have an expiry date of 7/31/2014. These medical devices are intended to provide access to the sinus space for diagnostic and therapeutic procedures.
The recall was initiated because Acclarent determined that one single unit of this catheter was distributed past its expiry date. The distribution of the affected units was limited to the state of Texas.
Healthcare providers and facilities in Texas should check their inventory for this specific catalog number and lot. If the product is found, it should be removed from use and returned to Acclarent, Inc. according to the company's instructions.
The recalled product
- Product
- RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .
- Manufacturer
- Acclarent, Inc.
- Category
- Medical Device — Sinus Catheter
- Hazard
- Affected units
- 986
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 (3)
- Catalog number GC070RF
- Lot 120709i-cm
- Expiry 7/31/2014.
Distribution
Distributed in 1 state:
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