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New Search Back To Search Results   Medical Device Recalls Class 2 Recall Orbit 90 Date Recall Initiated September 26, 2006 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 Addition 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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