FDA Medical Device Recalls (openFDA)
Rusch Inc: 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.
- Recall number
- Z-0578-04
- Recalling firm
- Rusch Inc
- 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.
- Status
- Terminated
- Initiated
- 2004-02-03
- Posted
- 2004-07-20
- Terminated
- 2006-03-21
- Reason
- Valve cap may become loose and enter the air circuitry.
- Root cause
- Other
- Action
- Consignees were notified on 2/3/2004 via certified mail and telephone.
- Quantity
- 4060 pieces
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- 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;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CBP
- Firm FEI
- 2429473
- Firm city
- Duluth
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28