Class 2 Device Recall MicroClave 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set

• Date Initiated by Firm: August 01, 2022
• Create Date: September 09, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1720-2022
• Recall Event ID: 90726
• 510(K)Number: K100576
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer
• Code Information: Product Number: 12517-01 UDI Code: 0110887709047201172612013050105735675 0110887709047201172612013050105755784 0110887709047201172612013050105755788 0110887709047201172702013050105812525 Lot Numbers: 5735675 5755784 5755788 5812525 Product Number: A1099 UDI Codes: 0110887709053127172611013050105692378 Lot Numbers: 5692378 Product Number: A1129 UDI Code: 0110887709068190172612013050105755485 0110887709068190172701013050105772087 Lot Number 5755485 5772087 Product Number: A1132 UDI Code: 0110887709068350172701013050105772482 Lot Number: 5772482 Product Number: A1152 UDI Code: 0110887709071527172612013050105735432 0110887709071527172701013050105787700 Lot Number: 5735432 5787700 Product Number: MC330113 UDI Codes: 0110887709078120172612013050105746371 0110887709078120172612013050105755711 0110887709078120172701013050105789359 Lot Numbers: 5746371 5755711 5789359 Product Number: MC330246 UDI Codes: 0110887709081502172610013050105641882 0110887709081502172612013050105738474 0110887709081502172701013050105773798 0110887709081502172701013050105788509 0110887709081502172701013050105809713 Lot Numbers: 5641882 5738474 5773798 5788509 5809713 Product Number: MC330247 UDI Codes: 0110887709081519172612013050105745619 0110887709081519172612013050105756766 0110887709081519172701013050105777168 0110887709081519172701013050105789411 Lot Numbers: 5745619 5756766 5777168 5789411 Product Number: MC33056 UDI Code: 0110887709037301172701013050105772683 Lot Number: 5772683 Product Number: MC330605 UDI Code: 0110887709097008172701013050105789539 Lot Number: 5789539 Product Number: MC33122 UDI Codes: 0110887709037400172612013050105757061 0110887709037400172701013050105772640 0110887709037400172701013050105788745 Lot Numbers: 5757061 5772640 5788745 Product Number: MC33213 UDI Codes: 0110887709037516172612013050105736601 0110887709037516172701013050105789780 0110887709037516172701013050105789784 Lot Numbers: 5736601 5789780 5789784 Product Number: MC33326 UDI Codes: 0110887709037752172612013050105757376 0110887709037752172701013050105772627 0110887709037752172701013050105772638 0110887709037752172702013050105810377 Lot Numbers: 5757376 5772627 5772638 5810377 Product Number: MC33600 UDI Code: 0110887709051932172701013050105789950 Lot Number: 5789950 Product Number: MC33729 UDI Codes: 0110887709065045172701013050105789984 0110887709065045172701013050105800993 Lot Numbers: 5789984 5800993 Product Number: MC33786 UDI Code: 0110887709067551172701013050105778247 Lot Number: 5778247 Product Number: Z3419 UDI Code: 0110887709032108172612013050105754551 Lot Number: 5754551 Product Number: Z3678 UDI Codes: 0110887709034607172612013050105754702 0110887709034607172701013050105777801 Lot Numbers: 5754702 5777801
• 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 = FPA and Original Applicant = ICU MEDICAL, INC.