Drug recall
Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as…
FDA recall event 83000 · Class II · Medline Industries, Inc.
Key facts
| Event ID | 83000 |
|---|---|
| Recall numbers | Z-1984-2019 |
| Recalling firm | Medline Industries, Inc. |
| Product type | Devices |
| Products | Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties. |
| Initiation date | May 30, 2019 |
| Report date | Jul 24, 2019 |
| City | Waukegan |
| State | IL |
| Country | United States |
| FEI number | 3000717925 |
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: