IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for us
FDA device recall Z-2422-2015 · posted 2015-08-19 · Terminated
Recall details
- Recalling firm
- International Biophysics Corp.
- Reason for recall
- It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
- Action taken
- The recalling firm began notifying their affacted customers on 7/2/2015
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DTS
- Quantity affected
- 100 units
- Distribution
- Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa
- Date initiated
- 2015-08-07
- Date posted
- 2015-08-19
- Date terminated
- 2016-03-01
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IBC CARDIAC SUCTION WARD (K963756) | International Biophysics Corp. | 1997-11-14 |