Class 2 Device Recall MicroClave

• Date Initiated by Firm: August 01, 2022
• Create Date: September 09, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1724-2022
• Recall Event ID: 90726
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer
• Code Information: Product Numbers / Lot Numbers / UDI Codes: IR-1SF 5727531 01549878920700181724120130100105727531 IR-1S 5728008 01549878920698901724120130100105728008 IR-1SF 5737373 01549878920700181724120130100105737373 IR-1S 5738091 01549878920698901724120130100105738091 IR-1S 5755100 01549878920698901724120130100105755100 P039 5787453 0110840619063112172501013050105787453 MC33769 5664461 0110887709066844172610013050105664461 K7059-001 5692316 0110887709036977172611013050105692316 011-MC100G 5693573 01108406190790141726110130100105693573 LAT-MC100 5714006 01108877090962851726110130100105714006 LAT-MC330021 5714014 0110887709122144172611013050105714014 MC100-DC 5724498 0110887709037165172612013050105724498 MC33636 5725526 0110887709058108172612013050105725526 MC33691 5725559 0110887709064314172612013050105725559 011-MC100RR 5726283 01108406190539771726120130100105726283 011-AM3120 5726777 0110887709098876172612013025105726777 066-MC100 5735598 01108406190842231726120130100105735598 039-MC330487 5736333 0110840619098541172612013025105736333 011-H3095 5737883 0110840619043015172612013025105737883 011-MC330627 5738780 0110887709098531172612013050105738780 MC33687 5744883 0110887709064369172612013050105744883 011-MC330526 5746749 0110887709092232172612013050105746749 011-MC33428 5747264 0110840619072336172612013025105747264 011-MC33830 5747331 0110840619038578172612013025105747331 011-MC33230 5747967 0110840619064492172612013050105747967 MC33324 5753823 0110887709037738172612013025105753823 MC33467 5754104 0110887709039046172612013025105754104 MC33769 5754294 0110887709066844172612013050105754294 011-MC330164 5756448 0110840619091085172612013020105756448 011-MC33108 5757000 0110840619057838172612013050105757000 MC33688 5757503 0110887709064376172612013050105757503 011-MC33727 5758006 0110840619077713172612013050105758006 011-A1027 5759727 0110840619064676172261201350105759727 011-MC330283 5761603 0110840619092914172612013050105761603 MC33324 5762312 0110887709037738172612013025105762312 MC33687 5762576 0110887709064369172612013050105762576 MC33634 5763303 0110887709058085172701013050105763303 K7059-001 5772085 0110887709036977172701013050105772085 MC33481 5772173 0110887709051864172701013025105772173 MC33467 5772198 0110887709039046172701013025105772198 MC33769 5772352 0110887709066844172701013050105772352 011-MC33872 5772480 0110840619081284172701013050105772480 011-MC33183 5773272 0110840619061743172701013050105773272 011-MC33428 5774716 0110840619072336172701013025105774716 011-MC33474 5774726 0110840619066380172701013050105774726 011-MC5006 5775730 0110840619072657172701013025105775730 K7047-001 5777730 01108877090368541727010130100105777730 011-MC330166 5782915 0110840619090064172701013050105782915 011-MC33057 5782920 0110840619055292172701013050105782920 011-MC330631 5782922 0110887709120225172701013050105782922 011-MC33471 5782923 0110840619066212172701013050105782923 011-MC33109 5782941 0110840619057845172701013050105782941 011-MC330074 5785884 0110840619086913172701013050105785884 011-MC33473 5787377 0110840619066403172701013050105787377 011-MC33740 5788332 0110840619078154172701013025105788332 011-MC330283 5788847 0110840619092914172701013050105788847 011-MC33044 5788907 0110840619054684172701013025105788907 011-MC33474 5789113 0110840619066380172701013050105789113 011-MC330074 5797110 0110840619086913172701013050105797110 011-MC33044 5800894 0110840619054684172701013025105800894 MC33481 5800914 0110887709051864172701013025105800914 MC33634 5800955 0110887709058085172701013050105800955 011-AM3120 5801154 0110887709098876172701013025105801154 LAT-MC100 5809570 01108877090962851727020130100105809570 011-MC330631 5816279 0110887709120225172702013050105816279 011-MC33230 5837430 0110840619064492172702013050105837430
• Recalling Firm/ Manufacturer: ICU Medical, Inc.; 951 Calle Amanecer; San Clemente CA 92673-6212
• For Additional Information Contact: Customer Service; 868-829-9025 Ext. 8
• Manufacturer Reason for Recall: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
• FDA Determined Cause: Process control
• Action: On 08/01/2022, ICU Medical, Inc. communicated an "URGENT: MEDICAL DEVICE RECALL" Letter via certified mail to inform customers that a manufacturing defect has been identified which results in a visible gap between the MicroClave Clear connector's top and bottom housing. This defect may potentially cause or lead to delayed delivery of infusion solution during setup/infusion, fluid leak, blood loss/exposure to patient blood, air embolism, exposure to allergenic/caustic substances, or fluid path contamination. Required Actions for Users: 1) Discontinue the use and distribution of the affected product immediately. Check inventory and quarantine all affected product at their facility. ted product. 2) Return affected product using the return label provided with this letter. Contact Sedgwick at 1-888-965-5798 (MF, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product. The return labels are for single use only. Please do not reproduce. Please visit http://expertezlabel.com to request additional labels for returning affected product. To ensure proper and timely credit, follow the instructions on the return label for returning product. Upon receipt of the completed response form and return of the affected product, ICU Medical will credit you for any product returned. You will only receive credit for product that you return. NOTE: Credits for product purchased through distributor will be credited by the distributor. 4) If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Sedgwick at 1-888-965-5798 (M-F, 8am-5pm ET) to obtain a response form. For questions - contact Customer Service 1-866-8295, option 8 or customerservice@icumed.com (M-F, 8am-6pm CT)
• Quantity in Commerce: Total of all affected units = 5,795,989 units
• Distribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Austria, Bahrain, Belgium, Canada, Colombia, Estonia, France, Germany, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam. O.U.S.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.