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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Visum 300

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 Class 2 Recall
Stryker Visum 300
see related information
Date Posted August 21, 2013
Recall Status1 Open
Recall Number Z-1992-2013
Recall Event ID 65888
Product Classification Device, Medical Examination, Ac Powered - Product Code KZF
Product Stryker Visum 300 Ceiling-mounted Exam Light.
Code Information Product sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013.
Recalling Firm/
Manufacturer
Stryker Communications
1410 Lakeside Pkwy Ste 100
Flower Mound, Texas 75028-4026
Manufacturer Reason
for Recall
Potential incomplete final weld on the drop tube flange.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The firm decided to recall and notified consignees with an "Urgent Medical Device Correction/Removal" notification letter dated 07/29/13. The product issue was described and recommended actions were provided. Customers may contact Stryker Technical Support at 866-841-5663.
Quantity in Commerce 1,375 units
Distribution Worldwide Distribution: US natiowide and to the country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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