Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2015-01-22 | VAI | Voluntary action indicated | Hurricane Medical, Inc. | 6 |
| 2015-01-22 | VAI | Voluntary action indicated | Hurricane Medical, Inc. | 6 |
| 2011-07-05 | VAI | Voluntary action indicated | Hurricane Medical, Inc. | 6 |
| 2011-07-05 | VAI | Voluntary action indicated | Hurricane Medical, Inc. | 6 |
Similar devices
- "Bone Marrow ""I"" Needle" REMINGTON MEDICAL, INC.
- "Bone Marrow ""I"" Needle" REMINGTON MEDICAL, INC.
- "Bone Marrow ""J"" Needle with Double Diamond Tip" REMINGTON MEDICAL, INC.
- "Bone Marrow ""J"" Needle with Double Diamond Tip" REMINGTON MEDICAL, INC.
- "Bone Marrow ""J"" Needle Double Diamond Tip" REMINGTON MEDICAL, INC.
- "Bone Marrow ""J"" Needle Double Diamond Tip" REMINGTON MEDICAL, INC.
- "DISP PERIBULBAR NEEDLE 25GA 7/8"" 10/BOX" KATENA PRODUCTS, INC.
- "K-Pack II Needle 27 GA x 0.75"" T.W. (0,4 x 20mm)" MERZ NORTH AMERICA, INC.
- "SOL-M Blunt Fill Needle 18G*1 1/2""" Sol-Millennium Medical, Inc.
- "SOL-M Blunt Fill Needle w/Filter 18G*1 1/2""" Sol-Millennium Medical, Inc.
- Aero-Med AERO-MED, LLC
- Aero-Med AERO-MED, LLC
Select up to two to place side-by-side with this device.