Drug recall
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery…
FDA recall event 72285 · Class II · Ethicon Endo-Surgery Inc
Key facts
| Event ID | 72285 |
|---|---|
| Recall numbers | Z-0278-2016 |
| Recalling firm | Ethicon Endo-Surgery Inc |
| Product type | Devices |
| Products | HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging. |
| Initiation date | Sep 23, 2015 |
| Report date | Nov 25, 2015 |
| Termination date | Nov 1, 2016 |
| City | Blue Ash |
| State | OH |
| Country | United States |
| FEI number | 1527736 |
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: