FDA Medical Device Recalls (openFDA)
International Biophysics Corp: IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX.
- Recall number
- Z-1222-06
- Recalling firm
- International Biophysics Corp
- Product
- IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX.
- Status
- Terminated
- Initiated
- 2005-08-16
- Posted
- 2006-07-12
- Terminated
- 2006-07-17
- Reason
- Tyvek pouches containing device labeled as sterile have defective seals.
- Root cause
- Other
- Action
- Firm notified customer via telephone on 08/16/05.
- Quantity
- 179 units.
- Distribution
- Product distributed to one hospital located in FL.
- Lot, serial or model codes
- Lot #042805-100335.
- 510(k) numbers
- ["K841959"]
- PMA numbers
- not on file
- Product code
- DWE
- 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