Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. C
FDA device recall Z-0261-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Vital Concepts, Inc.
- Reason for recall
- The probe may separate from the cannula.
- Action taken
- Recall letters dated November 7, 2003 were sent to each consignee asking them to return any remaining products in inventory or in the field.
- Root cause
- Other
- Status
- Terminated
- Product code
- BYY
- Quantity affected
- 3045
- Distribution
- Arizona, Illinois, Indiana, Michigan and Pennsylvania.
- Date initiated
- 2003-11-07
- Date posted
- 2004-07-20
- Date terminated
- 2004-09-13
- Location
- Grand Rapids, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VCI SUCTION/IRRIGATION TUBING SET (K934382) | Vital Concepts, Inc. | 1994-02-01 |