IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
FDA Recall Z-2424-2015 · Posted 2015-08-19
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Recalling FirmInternational Biophysics Corp.
Recall StatusTerminated
Product CodeDWS
Date Initiated2015-08-07
Date Terminated2016-03-01
Product Quantity771 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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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