Drug recall
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
FDA recall event 78777 · Class II · Hologic, Inc.
Key facts
| Event ID | 78777 |
|---|---|
| Recall numbers | Z-0351-2018 |
| Recalling firm | Hologic, Inc. |
| Product type | Devices |
| Products | Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the… |
| Initiation date | Jul 7, 2017 |
| Report date | Jan 24, 2018 |
| Termination date | Apr 4, 2018 |
| City | Danbury |
| State | CT |
| Country | United States |
| FEI number | 1220984 |
At a glance
- 1–9 Products in this recall
- 10–99 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: