Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall IBC Suction Wand

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall IBC Suction Wand see related information
Date Initiated by Firm October 05, 2011
Date Posted November 23, 2011
Recall Status1 Terminated 3 on March 23, 2012
Recall Number Z-0273-2012
Recall Event ID 60123
510(K)Number K963756  
Product Classification Sucker, cardiotomy return, cardiopulmonary bypass - Product Code DTS
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.
Code Information IBC 041811-2065
Recalling Firm/
Manufacturer		 International Biophysics Corp
2101-2 E Saint Elmo, Ste 275
Austin TX 78744
For Additional Information Contact Amy Bertling
512-814-0070
Manufacturer Reason
for Recall		 Potential for the sterility to be compromised.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DTS and Original Applicant = INTERNATIONAL BIOPHYSICS CORP.
-
-