Home › Gyrus ACMI, LLC › GYRUS ACMI, INC
GYRUS ACMI, INC
Gyrus ACMI, LLC · Model 230666 · UDI-DI 00821925018105
KAM
Prescription
10
510(k) clearances
61
Adverse events (1 deaths)
2
Recalls
56
Facilities
Description
SEPTAL NEEDLE STRAIGHT WITH LUER LOCK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-04-28 | Acclarent, Inc. | Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date. |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.