IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBE
FDA device recall Z-0273-2012 · posted 2011-11-23 · Terminated
Recall details
- Recalling firm
- International Biophysics Corp
- Reason for recall
- Potential for the sterility to be compromised.
- Action taken
- International Biophysics Corp. sent a" Medical Device Recall Notice" dated October 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Use of the product in the referenced lot number should cease immediately. Customers were asked to follow the instructions in the letter to return the affected product. If you have any further questions please call (512) 814-0070.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- DTS
- Quantity affected
- 1200 units
- Distribution
- Nationwide Distribution including the states of AZ, CA, CO, DE, MS, OR, PA, TN, and TX
- Date initiated
- 2011-10-05
- Date posted
- 2011-11-23
- Date terminated
- 2012-03-23
- 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 |