FDA Medical Device Recalls (openFDA)
International Biophysics Corp.: IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
- Recall number
- Z-2422-2015
- Recalling firm
- International Biophysics Corp.
- Product
- IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
- Status
- Terminated
- Initiated
- 2015-08-07
- Posted
- 2015-08-19
- Terminated
- 2016-03-01
- Reason
- It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
- Root cause
- Packaging process control
- Action
- The recalling firm began notifying their affacted customers on 7/2/2015
- Quantity
- 100 units
- Distribution
- Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa
- Lot, serial or model codes
- 033115-3445
- 510(k) numbers
- ["K963756"]
- PMA numbers
- not on file
- Product code
- DTS
- Firm FEI
- 1000117854
- Firm city
- Austin
- Firm state
- TX
- 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