FDA Medical Device Recalls (openFDA)
Vital Concepts, Inc.: HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
- Recall number
- Z-0022-04
- Recalling firm
- Vital Concepts, Inc.
- Product
- HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
- Status
- Terminated
- Initiated
- 2003-07-11
- Posted
- 2003-10-15
- Terminated
- 2004-04-12
- Reason
- The suction valve may become stuck in the 'suction on' position under vacuum.
- Root cause
- Other
- Action
- A request for product return was sent to each customer beginning on July 11, 2003.
- Quantity
- 196
- Distribution
- Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan
- Lot, serial or model codes
- lots 50904972 and 50905039.
- 510(k) numbers
- ["K934382","K960616"]
- PMA numbers
- not on file
- Product code
- GCY
- Firm FEI
- 1000115375
- Firm city
- Grand Rapids
- Firm state
- MI
- 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