FDA Device recall Z-1740-2015
RELIEVA FLEX Sinus Guide Catheter F-70
- FDA Device
- Class III
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class III recall of RELIEVA FLEX Sinus Guide Catheter F-70 by Acclarent, citing acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1740-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-04-28 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Acclarent |
| Distribution | TX |
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. .
Reason
Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
Identifiers
| code_info | Catalog number GC070RF, Lot 120709i-cm, Expiry 7/31/2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Acclarent
- TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
FDA Device · Class II · 2023-11-01 · Acclarent - TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z
FDA Device · Class II · 2021-12-29 · Acclarent - TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
FDA Device · Class II · 2020-01-29 · Acclarent - TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
FDA Device · Class II · 2020-01-29 · Acclarent - TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
FDA Device · Class II · 2020-01-29 · Acclarent
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1740-2015%22
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