Z-0273-2012

IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE)...

Name: Z-0273-2012 IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE)...
Creator: International Biophysics Corp
Published: 2011-10-05
License: https://open.fda.gov/license/

International Biophysics Corp. / initiated 2011-10-05 / Terminated / root cause: packaging

FDA source

International Biophysics Corp began a recall of IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065... on 2011-10-05. The reason FDA records is "Potential for the sterility to be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0273-2012
Status: Terminated
Initiated: 2011-10-05
Posted: 2011-11-23
Terminated: 2012-03-23
Recalling firm: International Biophysics Corp.
Product: 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.
Product code: DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Reason for recall: Potential for the sterility to be compromised.
Root cause tag: packaging
FDA 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 in commerce: 1200 units
Distribution: Nationwide Distribution including the states of AZ, CA, CO, DE, MS, OR, PA, TN, and TX
Product codes and lots: IBC 041811-2065

Product code DTS

K963756Class IIIbc Cardiac Suction WardInternational Biophysics Corp. / cleared 1997-11-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)