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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Orbit 90		see related information
Date Posted August 16, 2007
Recall Number Z-1166-2007
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
For Additional Information Contact Dale Fairchild
801-264-1384
Reason for
Recall		 The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.
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
 
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