FDA Recall
Terminated
Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United States Surgical brand
Recall: Z-0261-04
·
Initiated November 7, 2003
Recall
- Recall Number
- Z-0261-04
- Event Number
- 27694
- Firm
- Vital Concepts, Inc.
- FEI Number
- 1000115375
- Product Code
- BYY
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 7, 2003
- Posted
- July 20, 2004
- Terminated
- September 13, 2004
- Address
- 5090 Kendrick Ct Se, Grand Rapids, MI, 49512-9649
Description
Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United States Surgical brand
Reason
The probe may separate from the cannula.
Action
Recall letters dated November 7, 2003 were sent to each consignee asking them to return any remaining products in inventory or in the field.
Distribution
Arizona, Illinois, Indiana, Michigan and Pennsylvania.
Quantity
3045