FDA Medical Device Recalls (openFDA)
Rusch Inc: RFMD T-Piece With 2 one-way valves & tubing, Ref 395940, 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-0579-04
- Recalling firm
- Rusch Inc
- Product
- RFMD T-Piece With 2 one-way valves & tubing, Ref 395940, 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
- 13560 pieces
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Catalog No. 395940, Lot numbers: 108273, 109600, 111314, 111229, 113984, 113932, 113931, 112991, 112514, 111588, 111589, 111558, 111557, 117867, 117866, 116471, 116163, 115616, 114992, 116865, 118714, 118055, 118054, 118053, 119421, 120628, 120521, 120021,120741, 120742, 122619, 122621, 122620, 123017, 123016, 123837, 126217, 125471, 125117, 124069, 126626, 126625, 127052, 127051, 128481, 128322, 127549, 127550, 129360, 129109, 129991, 130186, 130187.
- 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