Z-1568-05

Bard * Davol Reliavac 400 Closed Wound Suction Kit * Sterile/EO * Single use * Medium-Large 3/16'' (15 Fr...

Name: Z-1568-05 Bard * Davol Reliavac 400 Closed Wound Suction Kit * Sterile/EO * Single use * Medium-Large 3/16'' (15 Fr...
Creator: C.R. Bard, Inc., Urological Division
Published: 2005-08-17
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2005-08-17 / Terminated

FDA source

C.R. Bard, Inc., Urological Division began a recall of 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... on 2005-08-17. The reason FDA records is "An incorrect Y-connector was placed in the kit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1568-05
Status: Terminated
Initiated: 2005-08-17
Posted: 2005-09-21
Terminated: 2009-08-21
Recalling firm: C.R. Bard Inc
Product: 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.
Product code: GBX Catheter, Irrigation
Reason for recall: An incorrect Y-connector was placed in the kit.
FDA root cause: Other
Action: Consignees were notified by letter on/about 08/17/2005
Quantity in commerce: 360 units
Distribution: AL, CA, FL, GA, IL, IN, NJ, TN, TX, Belgium and Japan
Product codes and lots: Catalog Number: 0034630, Lot Number: NGPE0150

Product code GBX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)