Stryker brand Neptune waste management system; model 711-27-1.
FDA device recall Z-0524-03 · posted 2003-02-01 · Terminated
Recall details
- Recalling firm
- Stryker Instruments, Instruments Div.
- Reason for recall
- Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.
- Action taken
- Each account was contacted by phone, beginning on December 3, 2002 and advised to refrain from using the units until repairs could be performed. A recall notification letter dated December 6, 2002 was sent to each account informing them of the recall and of plans for repairs.
- Root cause
- Other
- Status
- Terminated
- Product code
- FYD
- Quantity affected
- 370
- Distribution
- United States
- Date initiated
- 2002-12-03
- Date posted
- 2003-02-01
- Date terminated
- 2003-07-07
- Location
- Kalamazoo, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEPTUNE WASTE MANAGEMENT STSTEM (K012991) | Stryker Instruments | 2001-11-29 |
| NEPTUNE WASTE MANAGEMENT SYSTEM (K990037) | American Immuno Tech | 1999-08-24 |