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.
FDA Recall Z-1568-05 · Posted 2005-09-21
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Recalling FirmC.R. Bard, Inc., Urological Division
Recall StatusTerminated
Product CodeGBX
Date Initiated2005-08-17
Date Terminated2009-08-21
Product Quantity360 units
Reason for Recall
An incorrect Y-connector was placed in the kit.
Firm Action
Consignees were notified by letter on/about 08/17/2005
Root Cause
Other
Distribution Pattern
AL, CA, FL, GA, IL, IN, NJ, TN, TX, Belgium and Japan
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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