Recall Z-0273-2012 ยท DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
International Biophysics Corp
IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065 EXPIRATION DATE: 18/APR/2015 For use in open heart procedures, Autologus blood recovery or blood suction. Product is a component of Blood Recovery Systems.
| Date | Nov 23, 2011 (initiated Oct 5, 2011) |
| Status | Terminated |
| Reason | Potential for the sterility to be compromised. |
| Root cause | Packaging |
| Action | 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. |
| Quantity | 1200 units |
| Distribution | Nationwide Distribution including the states of AZ, CA, CO, DE, MS, OR, PA, TN, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963756 | IBC CARDIAC SUCTION WARD International Biophysics Corp., Nov 14, 1997 |