Drug recall
Spinning Spiros Closed Male Luer, REF: AH2000S
FDA recall event 86741 · Class II · ICU Medical, Inc.
Key facts
| Event ID | 86741 |
|---|---|
| Recall numbers | V-0031-2021 |
| Recalling firm | ICU Medical, Inc. |
| Product type | Veterinary |
| Products | Spinning Spiros Closed Male Luer, REF: AH2000S |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous… |
| Initiation date | Aug 31, 2020 |
| Report date | Dec 2, 2020 |
| City | San Clemente |
| State | CA |
| Country | United States |
| FEI number | 2025816 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: