Z-0578-04

4-Way Tee with 2 one-way valves, Ref 395945 Lot***, SINGLE USE ONLY, Qty 1 ea, RUSCH 2450 Meadowbrook...

Name: Z-0578-04 4-Way Tee with 2 one-way valves, Ref 395945 Lot***, SINGLE USE ONLY, Qty 1 ea, RUSCH 2450 Meadowbrook...
Creator: Rusch Inc
Published: 2004-02-03
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2004-02-03 / Terminated

FDA source

Rusch Inc began a recall of 4-Way Tee with 2 one-way valves, Ref 395945 Lot***, SINGLE USE ONLY, Qty 1 ea, RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098***. Carton labeling was similar... on 2004-02-03. The reason FDA records is "Valve cap may become loose and enter the air circuitry". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0578-04
Status: Terminated
Initiated: 2004-02-03
Posted: 2004-07-20
Terminated: 2006-03-21
Recalling firm: Teleflex Medical
Product: 4-Way Tee with 2 one-way valves, Ref 395945 Lot***, SINGLE USE ONLY, Qty 1 ea, RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098***. Carton labeling was similar to individual unit labeling, except for, ***Qty 50 ea.
Product code: CBP Valve, Non-Rebreathing
Reason for recall: Valve cap may become loose and enter the air circuitry.
FDA root cause: Other
Action: Consignees were notified on 2/3/2004 via certified mail and telephone.
Quantity in commerce: 4060 pieces
Distribution: Nationwide and Canada
Product codes and lots: Catalog No.: 395945, Lot numbers: 116040, 116039, 114795, 113887, 113886, 113232, 113230, 113095, 113027, 119110, 118134, 119988, 119989, 129179, 128393, 128028, 126119, 126118, 124951, 123197, 123198, 122461, 122033, 131793, 120731;

Product code CBP

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)