Class 2 Device Recall MicroClave Clear Neutral Connector

• Date Initiated by Firm: August 01, 2022
• Create Date: September 09, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1719-2022
• Recall Event ID: 90726
• 510(K)Number: K100434
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
• Code Information: Product Number: MC100 UDI Code: 01108877090371581726110130100105716986 01108877090371581726110130100105716988 01108877090371581726110130100105716989 01108877090371581726110130100105716990 01108877090371581726110130100105716992 01108877090371581726110130100105716993 01108877090371581726110130100105716994 01108877090371581726120130100105737649 01108877090371581726120130100105737651 01108877090371581726120130100105739477 01108877090371581726120130100105739478 01108877090371581726120130100105739482 01108877090371581726120130100105739484 01108877090371581726120130100105739493 01108877090371581726120130100105755652 01108877090371581726120130100105757425 01108877090371581726120130100105757426 01108877090371581727010130100105771936 01108877090371581727010130100105771950 01108877090371581727010130100105771956 01108877090371581727010130100105786565 01108877090371581727010130100105815050 Lot Numbers: 5716986 5716988 5716989 5716990 5716992 5716993 5716994 5737649 5737651 5739477 5739478 5739482 5739484 5739493 5755652 5757425 5757426 5771936 5771950 5771956 5786565 5815050 Product Number: 12512-01 UDI Codes: 01108877090505391726120130100105724458 01108877090505391726120130100105736445 01108877090505391726120130100105739485 01108877090505391726120130100105739486 01108877090505391726120130100105739487 01108877090505391726120130100105739488 01108877090505391726120130100105754899 01108877090505391727010130100105771934 01108877090505391727010130100105793264 01108877090505391727010130100105798239 01108877090505391727010130100105802842 01108877090505391727020130100105812522 Lot Numbers: 5724458 5736445 5739485 5739486 5739487 5739488 5754899 5771934 5793264 5798239 5802842 5812522 Product Number: MC100-PR UDI Code: 01108877090372021726120130100105738352 Lot Number 5738352 Product Number: MC330446 UDI Code: 0110887709089096172612013050105746457 Lot Number: 5746457 Product Number: MC330545 UDI Code: 0110887709093222172701013050105773182 Lot Number: 5773182
• 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.