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U.S. Department of Health and Human Services

Class 2 Device Recall Orbit 90

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  Class 2 Device Recall Orbit 90 see related information
Date Initiated by Firm September 26, 2006
Date Posted August 16, 2007
Recall Status1 Terminated 3 on March 22, 2012
Recall Number Z-1166-2007
Recall Event ID 38209
510(K)Number K033290  
Product Classification infusion set - Product Code FPA
Product Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291
Code Information 414371,414372,414373,433069,433070,453469,453470,453471,488549,488550,488551,488552,488553,488554,
Recalling Firm/
ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact Dale Fairchild
Manufacturer Reason
for Recall
The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.
FDA Determined
Cause 2
Action Firm mailed a letter dated September 26, 2006 to notify customers of the recall. The letter advises the product contains a female luer which has been reported to crack in use allowing fluid to leak from the device. Customers are asked that if they have inventory of the lots identified to quarantine these lots and contact your consignees of this recall and return the product immediately for destruction. They are asked to complete and return the attached product inventory summary sheet in the enclosed self-addressed stamped envelope and return product to ICU Medical.
Quantity in Commerce 26,361 units
Distribution VA, OH, TX, CA, GA
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = ICU MEDICAL, INC.