FDA Recall
Terminated
Irrigation aspiration system for Nexhat Dorsey type pumps with 33 cm probe and tubing, latex free, catalog # 55050. Sterile, single use. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan.
Recall: Z-0259-04
·
Initiated November 7, 2003
Recall
- Recall Number
- Z-0259-04
- 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
Irrigation aspiration system for Nexhat Dorsey type pumps with 33 cm probe and tubing, latex free, catalog # 55050. Sterile, single use. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan.
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