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Terminated

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.

FDA Recall Z-0273-2012 · Posted 2011-11-23

Recalling FirmInternational Biophysics Corp
Recall StatusTerminated
Product CodeDTS
Date Initiated2011-10-05
Date Terminated2012-03-23
Product Quantity1200 units

Reason for Recall

Potential for the sterility to be compromised.

Firm 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.

Root Cause

Packaging

Distribution Pattern

Nationwide Distribution including the states of AZ, CA, CO, DE, MS, OR, PA, TN, and TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K963756IBC CARDIAC SUCTION WARDInternational Biophysics Corp. · 1997-11-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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