| Date Initiated by Firm | August 07, 2015 |
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| Date Posted | August 19, 2015 |
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| Recall Status1 |
Terminated 3 on March 01, 2016 |
| Recall Number | Z-2422-2015 |
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| Recall Event ID |
71911 |
| 510(K)Number | K963756 |
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| 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. |
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| 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 |
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Manufacturer Reason
for Recall | It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. |
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FDA Determined
Cause 2 | Packaging process control |
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| Action | The recalling firm began notifying their affacted customers on 7/2/2015 |
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| Quantity in Commerce | 100 units |
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| Distribution | Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa |
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| Total Product Life Cycle | TPLC Device Report |
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|
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.
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| 510(K) Database | 510(K)s with Product Code = DTS
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