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.
This recall has been terminated (originally issued September 21, 2005).
- Recall Initiated
- August 17, 2005
- Posted
- September 21, 2005
- Terminated
- August 21, 2009
- Recall Number
- Z-1568-05
- Quantity
- 360 units
- Firm Location
- Covington, GA
- Official Source
- View on FDA website ↗
Reason for Recall
An incorrect Y-connector was placed in the kit.
Distribution
AL, CA, FL, GA, IL, IN, NJ, TN, TX, Belgium and Japan
Lot / Code Info
Catalog Number: 0034630, Lot Number: NGPE0150
Root Cause
Other
Action Taken
Consignees were notified by letter on/about 08/17/2005
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