FDA Medical Device Recalls (openFDA)
Rusch Inc: One Way Valve/Female to Male Flow, 22 mm I.D./22 mm O.D., Ref 396798, Lot ***, SINGLE USE ONLY, Latex Free, Quantity 50 Each Manufactured for and Distributed by RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098, Made in Taiwan.
- Recall number
- Z-0581-04
- Recalling firm
- Rusch Inc
- Product
- One Way Valve/Female to Male Flow, 22 mm I.D./22 mm O.D., Ref 396798, Lot ***, SINGLE USE ONLY, Latex Free, Quantity 50 Each Manufactured for and Distributed by RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098, Made in Taiwan.
- 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
- 13300 pieces
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Catalog No.: 396798, Lot numbers: 020305, 010905, 020530, 020705, 020925, 021015, 021115, 030220, 030515, 030415, 030825, 030120.
- 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