FDA Recall
Terminated
Reorder # Lapkit 3. Contents: 1- 55060 suction/irrigation valve 2- 30012 insufflation tubing set 3- 5010 anti fog solution with sponge. Sterile. single use. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.
Recall: Z-0260-04
·
Initiated November 7, 2003
Recall
- Recall Number
- Z-0260-04
- 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
Reorder # Lapkit 3. Contents: 1- 55060 suction/irrigation valve 2- 30012 insufflation tubing set 3- 5010 anti fog solution with sponge. Sterile. single use. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.
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
70