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Class 2 Device Recall Vascular Loop |
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Date Initiated by Firm |
August 07, 2015 |
Date Posted |
August 19, 2015 |
Recall Status1 |
Terminated 3 on March 01, 2016 |
Recall Number |
Z-2424-2015 |
Recall Event ID |
71911 |
Product Classification |
Instruments, surgical, cardiovascular - Product Code DWS
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Product |
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.
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Code Information |
031715-3418, 050815-3513, 052115-3540, 033015-3435, 052115-3542, 031615-3417, 050815-3514, 052115-3543, 033015-3436, 050815-3515, 060915-3578, 041715-3478, 033015-3437, 050815-3516, 052215-3545, 042015-3482, 052115-3541 |
Recalling Firm/ Manufacturer |
International Biophysics Corp. Bldg 2, Ste 275 2101 E Saint Elmo Rd Austin TX 78744-1015
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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 |
Action |
The recalling firm began notifying their affacted customers on 7/2/2015 |
Quantity in Commerce |
771 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
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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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