Drug recall
Neptune 1 Gold Rover (120 Vand 230V) Waste Management System Part Number 0700-001-000…
FDA recall event 61747 · Class I · Stryker Instruments Div. of Stryker Corporation
Key facts
| Event ID | 61747 |
|---|---|
| Recall numbers | Z-2061-2012, Z-2062-2012, Z-2063-2012, Z-2064-2012 |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Product type | Devices |
| Products | Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical…, Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700, Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste., Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a… |
| Initiation date | Jun 8, 2012 |
| Report date | Aug 22, 2012 |
| Termination date | Aug 23, 2016 |
| City | Portage |
| State | MI |
| Country | United States |
| FEI number | 1811755 |
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: