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U.S. Department of Health and Human Services

Class 2 Device Recall IBC Suction Wand

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  Class 2 Device Recall IBC Suction Wand see related information
Date Initiated by Firm August 16, 2005
Date Posted July 12, 2006
Recall Status1 Terminated 3 on July 17, 2006
Recall Number Z-1222-06
Recall Event ID 35703
510(K)Number K841959  
Product Classification Tubing, Pump, Cardiopulmonary Bypass - Product Code DWE
Product IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX.
Code Information Lot #042805-100335.
Recalling Firm/
Manufacturer		 International Biophysics Corp
2101-2 E Saint Elmo, Ste 275
Austin TX 78744
Manufacturer Reason
for Recall		 Tyvek pouches containing device labeled as sterile have defective seals.
FDA Determined
Cause 2		 Other
Action Firm notified customer via telephone on 08/16/05.
Quantity in Commerce 179 units.
Distribution Product distributed to one hospital located in FL.
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 = DWE and Original Applicant = STERILE DESIGN, INC.
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