Drug recall
Lamicel 10PK 10MM INTL
FDA recall event 84332 · Class II · Medtronic Xomed, Inc.
Key facts
| Event ID | 84332 |
|---|---|
| Recall numbers | Z-0733-2020, Z-0734-2020, Z-0735-2020 |
| Recalling firm | Medtronic Xomed, Inc. |
| Product type | Devices |
| Products | Lamicel 10PK 10MM INTL, Lamicel 20PK 3MM INTL Cervical dilator, Lamicel 20PK 5MM INTL |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Routine sterilization dose does not meet the required Sterility Assurance Level. |
| Initiation date | Nov 13, 2019 |
| Report date | Jan 1, 2020 |
| City | Jacksonville |
| State | FL |
| Country | United States |
| FEI number | 1045254 |
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: