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.
FDA Recall Z-2422-2015 · Posted 2015-08-19
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Recalling FirmInternational Biophysics Corp.
Recall StatusTerminated
Product CodeDTS
Date Initiated2015-08-07
Date Terminated2016-03-01
Product Quantity100 units
Reason for Recall
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Firm Action
The recalling firm began notifying their affacted customers on 7/2/2015
Root Cause
Packaging process control
Distribution Pattern
Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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