Class 2 Device Recall Orbit and Orbit Micro

• Date Initiated by Firm: March 01, 2011
• Date Posted: January 11, 2012
• Recall Status: Terminated on February 22, 2013
• Recall Number: Z-0592-2012
• Recall Event ID: 60524
• 510(K)Number: K033290
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Orbit and Orbit Micro; ; Subcutaneous infusion set Triad alcohol wipes are co-packaged with the Orbit devices. Our device is within its own separate sterile package and the wipes are packaged with our devices within an outer container. Removal of the wipes will not compromise the sterile barrier of our device and can easily be identified and replaced.
• Code Information: Catalog # Lot # B7905: 2010928, 2010955, 2010956, 2026848, 2026849, 2026852. B7932: 2010961, 2012567, 2012965, 2022800. M1861: 1724481 M2461: 1701070. M2491: 1706450. M3060: 1711976. M3091: 1701069. M4261: 1711981. P1005: 1992939. P1850: 1887213. P1851: 1646310, 1646311, 1750036, 1863485, 1887212, 1972548, 2013176. P1861: 1385494, 1711980, 1752814. P1881: 2027824. P1891: 1471913. P2450: 1800862. P2451: 1598200, 1598201, 1598206, 1750038, 1800860, 1815008, 1851423, 1887209, 1887216, 1972553. P2460: 1470415, 1722014. P2461: 1087509, 1385394, 1598097, 1774378, 1803640, 1848045, 1971554, 2022098. P2481: 1999027, 1999484, 2022794, 2027826. P2491: 1363050, 1557296, 1692396, 1782845. P3051: 1366012, 1646308, 1646312, 1660580, 1660581, 1800858, 1841693, 1853574, 1887208, 1887215, 1887217, 1972556, 2027827. P3061: 1062302, 1087495, 1686643. P3081: 1919294, 1972551, 1978024, 2027828. P3091: 1244139, 1244140, 1244141, 1363051, 1598101, 1598102, 1686641, 1686644. P4251: 1646309, 1646313, 1871643, 2022795. P4260: 1439395. P4261: 1363053, 1722015. P4281: 2027825, 2045107. P4290: 1439397. P4291: 1363049, 1722019, 1761743, 1774372, 1774374, 1774375, 1774376, 1774377, 1774379, 1774380, 1782841, 1782842, 1782843, 1782844, 1799794, 1799795, 1799796, 1799797, 1799798, 1814994, 1848046, 1855183, 1972546, 2007344, 2027816. P4291M: 1863467, 186468, 1863469, 18687998, 1887999, 1888000, 1888001, 1888002, 1888003, 1888004, 1888005, 1888006, 1972538, 1972539, 1972542, 1975233, 1990393, 1990395, 1991948, 2006952, 2006953, 2006954, 2006955, 2007432, 2022118, 2026307, 2026308, 2026309, 2027903, 2027904, 2028415.
• Recalling Firm/ Manufacturer: ICU Medical, Inc.; 951 Calle Amanecer; San Clemente CA 92673
• For Additional Information Contact: 949-366-2183
• Manufacturer Reason for Recall: The recall was initiated because ICU Medical Inc. has become aware of the market recall of the Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names. The Triad alcohol prep pads have the potential contamination of the bacteria, Bacillus cereus. The Triad Group alcohol prep pads have been copackaged
• FDA Determined Cause: Pending
• Action: The firm, ICU Medical, Inc., sent an "IMPORTANT-Important Information About Triad Group's Alcohol Prep Pads" letter dated March 2, 2011 (via email) to their distributors. Hard copy notices were shipped (via next day express delivery with receipt confirmation) to all their customers. The Important letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were informed that the Orbit and Orbit Micro subcutaneous infusion sets as well as the IV start kits are not contaminated and may continue to be used according to the directions for use. The issue is confined to the actual Triad alcohol prep pad products. Patients and healthcare providers should not use the alcohol prep pads packaged with these devices and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall. ICU Medical has halted all shipments of product that contain the Triad alcohol prep products to its distribution network. An alternate wipe has been qualified and is now being shipped in new orders. Customers were instructed to forward the Important letter to their customers and on to any end users of the devices. For Orbit and Orbit Micro devices, patients are instructed to immediately discontinue using the Triad alcohol prep pads included in the Orbit packaging and dispose of those pads in the trash. Patients should use an alternative prep pad that is not subject to the Triad recall. For IV Start Kits, distributors and users are instructed to place the enclosed label on the device prior to use. Additional labels can be obtained by contacting ICU Customer Service Monday through Friday between the hours of 8:30AM and 4:00PM Pacific Standard time: (800) 866-9025 and select option 8, or email the following address: customerservice@icumed.com. Customers may also contact regulatory@icumed.com for MSWord template file for Avery 5160 labels and print additional labels. Customers were instructed to complete
• Quantity in Commerce: 376,290 units
• Distribution: Worldwide distribution: USA (Nationwide) and countries of: Austria, Belgium, Chile, Cyprus, CZ, France, Germany, Great Britain, Greece, Israel, Italy, Lithuania, Netherland, Poland, Russia, Saudi Arabia, Sweden, and Switzerland.
• 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.