FDA Medical Device Recalls (openFDA)
Vital Concepts, Inc.: Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United States Surgical brand
- Recall number
- Z-0261-04
- Recalling firm
- Vital Concepts, Inc.
- Product
- Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United States Surgical brand
- Status
- Terminated
- Initiated
- 2003-11-07
- Posted
- 2004-07-20
- Terminated
- 2004-09-13
- Reason
- The probe may separate from the cannula.
- Root cause
- Other
- Action
- Recall letters dated November 7, 2003 were sent to each consignee asking them to return any remaining products in inventory or in the field.
- Quantity
- 3045
- Distribution
- Arizona, Illinois, Indiana, Michigan and Pennsylvania.
- Lot, serial or model codes
- lots 50904937 and 50904995.
- 510(k) numbers
- ["K934382"]
- PMA numbers
- not on file
- Product code
- BYY
- 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