Drug recall
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
FDA recall event 89463 · Class II · Lacrimedics Inc
Key facts
| Event ID | 89463 |
|---|---|
| Recall numbers | Z-0708-2022, Z-0709-2022 |
| Recalling firm | Lacrimedics Inc |
| Product type | Devices |
| Products | Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment, OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. |
| Initiation date | Jan 17, 2022 |
| Report date | Mar 9, 2022 |
| City | Dupont |
| State | WA |
| Country | United States |
| FEI number | 2024818 |
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: