FDA Recall
Terminated
Bard * Davol Reliavac 400 Closed Wound Suction Kit * Sterile/EO * Single use * Medium-Large 3/16'' (15 Fr., 4.7mm) O.D. PVC Drain * 12.5'' (31.7cm) Hole Pattern, X-ray Opaque Stripe Attached Trocar * 400cc Evacuator ** Y-Connecting Tube * * C.R. Bard Inc., Covington, GA 30014. The product contains a 400cc Evacuator, Y-connector with drainage tube and a 3/116 PVC drain with trocar. These components are provided together in a kit but not preassembled.
Recall: Z-1568-05
·
Initiated August 17, 2005
Recall
- Recall Number
- Z-1568-05
- Event Number
- 33284
- Firm
- C.R. Bard, Inc., Urological Division
- FEI Number
- 1018233
- Product Code
- GBX
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 17, 2005
- Posted
- September 21, 2005
- Terminated
- August 21, 2009
- Address
- 8195 Industrial Blvd Ne, Covington, GA, 30014-1497
Description
Bard * Davol Reliavac 400 Closed Wound Suction Kit * Sterile/EO * Single use * Medium-Large 3/16'' (15 Fr., 4.7mm) O.D. PVC Drain * 12.5'' (31.7cm) Hole Pattern, X-ray Opaque Stripe Attached Trocar * 400cc Evacuator ** Y-Connecting Tube * * C.R. Bard Inc., Covington, GA 30014. The product contains a 400cc Evacuator, Y-connector with drainage tube and a 3/116 PVC drain with trocar. These components are provided together in a kit but not preassembled.
Reason
An incorrect Y-connector was placed in the kit.
Action
Consignees were notified by letter on/about 08/17/2005
Distribution
AL, CA, FL, GA, IL, IN, NJ, TN, TX, Belgium and Japan
Quantity
360 units