Class 2 Device Recall MicroClave Intravascular Administration Set

• Date Initiated by Firm: August 01, 2022
• Create Date: September 09, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1721-2022
• Recall Event ID: 90726
• 510(K)Number: K964435
• Product Classification: Stopcock, i.V. Set - Product Code FMG
• Product: 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock
• Code Information: Product Number: 011-MC33538 UDI Code: 0110840619072435172701013050105772700 Lot Numbers: 5772700 Product Number: A1009 UDI Codes: 0110887709051055172612013050105747112 Lot Numbers: 5747112 Product Number: A1129 UDI Code: 0110887709068190172612013050105755485 0110887709068190172701013050105772087 Lot Number 5755485 5772087 Product Number: AC235 UDI Code: 0110887709122069172702013050105782946 Lot Number: 5782946 Product Number: MB4V01 UDI Code: 0110887709079578172701013050105797658 Lot Number: 5797658 Product Number: MC330073 UDI Codes: 0110887709076690172612013050105724537 Lot Numbers: 5724537 Product Number: MC330255 UDI Codes: 0110887709081670172611013050105712884 Lot Numbers: 5712884 Product Number: MC3302R UDI Codes: 0110887709037271172612013050105745628 Lot Numbers: 5745628 Product Number: MC330362 UDI Code: 0110887709085319172701013050105772361 Lot Number: 5772361 Product Number: MC330417 UDI Code: 0110887709087504172701013050105782954 0110887709087504172702013050105816260 Lot Number: 5782954 5816260 Product Number: MC330476 UDI Codes: 0110887709090030172611013050105677797 0110887709090030172611013050105692512 0110887709090030172612013050105721748 Lot Numbers: 5677797 5692512 5721748 Product Number: MC330583 UDI Codes: 0110887709095868172701013050105773172 Lot Numbers: 5773172 Product Number: MC330611 UDI Codes: 0110887709097022172702013025105825526 0110887709097022172702013025105850314 Lot Numbers: 5825526 5850314 Product Number: MC330615 UDI Code: 0110887709097091172701013050105773186 0110887709097091172701013050105776699 Lot Number: 5773186 5776699 Product Number: MC33087 UDI Codes: 0110887709037349172612013050105732851 0110887709037349172701013050105757039 Lot Numbers: 5732851 5757039 Product Number: MC33092 UDI Code: 0110887709037356172612013050105757043 Lot Number: 5757043 Product Number: MC33119 UDI Code: 0110887709037394172611013050105692600 0110887709037394172612013050105725019 0110887709037394172701013050105777549 Lot Number: 5692600 5725019 5777549 Product Number: MC33196 UDI Codes: 0110887709057644172702013050105823306 Lot Numbers: 5823306 Product Number: MC3325 UDI Codes: 0110887709037547172611013050105679662 0110887709037547172701013050105772606 0110887709037547172701013050105772609 0110887709037547172701013050105772630 Lot Numbers: 5679662 5772606 5772609 5772630 Product Number: MC33290 UDI Codes: 0110887709037561172701013050105786080 0110887709037561172702013050105816255 Lot Numbers: 5786080 5816255 Product Number: MC33312 UDI Code: 0110887709037660172701013050105782876 0110887709037660172702013050105823287 Lot Numbers: 5782876 5823287 Product Number: MC33337 UDI Code: 0110887709037851172612013050105753046 Lot Number: 5753046 Product Number: MC33343 UDI Code: 0110887709037912172612013050105762347 Lot Number: 5762347 Product Number: MC33348 UDI Codes: 0110887709037967172612013050105753060 0110887709037967172612013050105762355 0110887709037967172701013050105789832 Lot Numbers: 5753060 5762355 5789832 Product Number: MC33409 UDI Codes: 0110887709038537172612013050105746703 0110887709038537172612013050105753968 Lot Numbers: 5746703 5753968 Product Number: MC33424 UCI Codes: 0110887709038674172701013050105778865 0110887709038674172701013050105789733 Lot Numbers: 5778865 5789733 Product Number: MC33425 UDI Codes: 0110887709038681172612013050105737011 0110887709038681172701013050105773212 0110887709038681172702013050105778871 Lot Numbers: 5737011 5773212 5778871 Product Number: MC33482 UDI Code: 0110887709039183172702013050105785919 Lot Number: 5785919 Product Number: MC33492 UDI Codes: 0110887709051871172612013050105754132 0110887709051871172701013050105772548 0110887709051871172701013050105778966 Lot Numbers: 5754132 5772548 5778966 Product Number:MC33493 UDI Code: 0110887709051888172611013050105684445 Lot Number: 5684445 Product Number: MC33547 UDI Code: 0110887709057804172612013050105753321 Lot Number: 5753321 Product Number: MC33563 UDI Codes: 0110887709057835172612013050105737877 0110887709057835172701013050105800935 Lot Numbers: 5737877 5800935 Product Number: MC33632 UDI Code: 0110887709058061172612013050105737895 Lot Number: 5737895 Product Number: MC33667 UDI Code: 0110887709062976172611013050105685338 Lot Number: 5685338 Product Number: MC33670 UDI Code: 0110887709063119172611013050105712886 Lot Number: 5712886 Product Number: MC33671 UDI Code: 0110887709063126172611013050105712863 Lot Number: 5712863 Product Number: MC33795 UDI Codes: 0110887709068046172611013050105712882 0110887709068046172701013050105778251 Lot Numbers: 5712882 5778251 Product Number: MC33917 UDI Code: 0110887709071602172612013050105757508 Lot Number: 5757508 Product Number: MC33980 UDI Codes: 0110887709075419172612013050105757494 0110887709075419172612013050105762677 Lot Numbers: 5757494 5762677 Product Number: MC33981 UDI Codes: 0110887709075426172701013050105778306 0110887709075426172701013050105800052 Lot Numbers: 5778306 5800052 Product Number: SC137 UDI Code: 0110887709040264172701013050105773207 Lot Number: 5773207 Product Number: Z3420 UDI Code: 0110887709032115172701013050105773199 Lot Number: 5773199 Product Number: Z3429 UDI Codes: 0110887709032207172612013050105749820 0110887709032207172702013050105825452 Lot Numbers: 5749820 5825452 Product Number: Z3523 UDI Code: 0110887709033082172701013050105788233 Lot Number: 5788233 Product Number: Z3574 UDI Codes: 0110887709033587172612013050105745063 0110887709033587172701013050105776728 Lot Numbers: 5745063 5776728
• 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.

• 510(K) Database: 510(K)s with Product Code = FMG