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U.S. Department of Health and Human Services

Class 2 Device Recall Suction Wand

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  Class 2 Device Recall Suction Wand see related information
Date Initiated by Firm August 07, 2015
Date Posted August 19, 2015
Recall Status1 Terminated 3 on March 01, 2016
Recall Number Z-2422-2015
Recall Event ID 71911
510(K)Number K963756  
Product Classification Sucker, cardiotomy return, cardiopulmonary bypass - Product Code DTS
Product IBC Suction Wand Catalog Number 1990S

Product Usage:
The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
Code Information 033115-3445
Recalling Firm/
Manufacturer		 International Biophysics Corp.
Bldg 2, Ste 275
2101 E Saint Elmo Rd
Austin TX 78744-1015
For Additional Information Contact Geoff Marcek
512-814-0046
Manufacturer Reason
for Recall		 It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
FDA Determined
Cause 2		 Packaging process control
Action The recalling firm began notifying their affacted customers on 7/2/2015
Quantity in Commerce 100 units
Distribution Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa
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.
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