FDA Medical Device Recalls (openFDA)
Vital Concepts, Inc.: Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
- Recall number
- Z-0021-04
- Recalling firm
- Vital Concepts, Inc.
- Product
- Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
- 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
- 2333
- Distribution
- Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan
- Lot, serial or model codes
- lots 50904840, 50904918, 50904919, 50904935, 50904958, 50904959, 50904988, 50904994, 50905033, 50905050A, 50905093, 50905121 and 50905148.
- 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