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U.S. Department of Health and Human Services

Class 2 Device Recall Orbit 90

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 Class 2 Recall
Orbit 90
see related information
Date Posted August 16, 2007
Recall Status1 Open
Recall Number Z-1166-2007
Recall Event ID 38209
Premarket Notification
510(K) Number
K033290 
Product Classification Set, Administration, Intravascular - 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/
Manufacturer
ICU Medical, Inc.
951 Calle Amanecer
San Clemente, California 92673-6212
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Dale Fairchild
801-264-1384
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
PRODUCTION CONTROLS: Process Control
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 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.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = ICU MEDICAL, INC.
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