30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL3011T; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3020; 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, Drop-In Red Cap, REF: CL3028; 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3028T; 42" (107 cm) Appx 5.2 ml, Admin Set w/20 Drop In-Line Chamber, ChemoLock w/Red Cap, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3361; Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock; Spinning Spiros w/Red Cap, REF: CL3538; Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, Spiros; ChemoLock; ChemoLock Universal Vented Vial Spike; Bag Hanger, REF CL3929; 8.5" (22 cm) Appx 1.0 ml, Ext Set w/MicroClave Clear, ChemoLock Port, Spiros w/Red Cap, Clamp, REF: CL3931; 7.5" (19 cm) Appx 1.1 ml, Bifuse Ext Set w/ChemoLock Port, ChemoClave, Spiros, 2 Clamps, REF: CL3932; 30 IN(76cm)APPX 2.1ml, EXT SET w/ChemoLock w/RED CAP, Spiros RED CAP, REF: CL3935; Oncology Kit w/ChemoLock w/ChemoClave; Spinning Spiros w/ Red Cap, REF: CL3941; Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock w/Red Cap, Vented Cap; ChemoLock Port w/Bag Spike; Spiros w/Red Cap, REF: CL3946; Oncology Kit, ChemoLock Bag Spike w/Additive Port, Vented Cap, Spiros, REF: CL3948; Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros, ChemoLock, Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960; Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros, ChemoLock, Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960T; 60" (152 cm) Appx 7.4 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL4100; 30" (76 cm) Appx 3.6 ml, Admin Set w/20 Drop In-Line Drip Chamber, ChemoLock Additive Port, Spiros w/Red Cap, REF: CL4131; 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer, REF: CL4151; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, Spiros w/Red Cap, Drop-In ChemoLock Injector, Bag Hanger, REF: CL3978
- Company
- Icu Medical, Inc.
- Recall Initiated
- August 31, 2020
- Recall Number
- Z-0703-2021
- Quantity
- 231250
- Firm Location
- Amanecer San Clemente, CA
Reason for Recall
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
Distribution
Worldwide distribution - U.S. Nationwide distribution including in the states of FL, MD, LA, PA, IN, TX, NY, MO, VA, OH, GA, NC, IL, CA, AZ, AK, NE, DE, WI, CO, UT, ND, MS, MA, MN, WA, SC, OR, KS, MI, NH, NJ, KY, TN, ID, AR, CT, OK, AL, SD, ME, IA, VT, WY, DC, NV, RI, MT, NM, HI, WV and the countries of Italy, Belgium, United Kingdom, Canada, Germany, Argentina, Australia, Poland, Greece, Switzerland, Israel, France, Finland, Spain, Malaysia, Taiwan, Ireland, Luxembourg, Hong Kong , Brazil, Netherlands, Austria, Sweden, Turkey, Singapore, Slovakia, Croatia, South Africa, Romania, Thailand.
Lot / Code Info
Lots: 4720479, 4724743, 4735699, 4775051, 4803047, 4808098, 4868079, 4868080, 4735696, 4763384, 4800367, 4866943, 4908482, 4724700, 4742639, 4758414, 4775030, 4787228, 4808060, 4848204, 4712385, 4724701, 4605106, 4733557, 4757782, 4775514, 4800370, 4724728, 4765922, 4867983, 4724703, 4749489, 4803140, 4878873, 4742641, 4758385, 4794501, 4720364, 4752843, 4799894, 4850394, 4866135, 4790865, 4735669, 4742630, 4758441, 4764898, 4787232, 4848213, 4867995, 4743901, 4765927, 4775070, 4777973, 4794503, 4606697, 4735662, 4803124, 4808069, 4867961, 4897098, 4898098, 4899830, 4573189, 4606684, 4749454, 4756268, 4803136, 4808059, 4848185, 4878880, 4726940, 4742091, 4738028, 4749474, 4560357, 4735675, 4714539, 4763384, 4800367, 4866943, 4908482, 4742641
Root Cause
Process control
Action Taken
On 08/31/2020, Medical Device Recall notices were mailed to customers informing them to take the following actions: 1) Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) Inform potential users of the product in your organization of this notification and complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if you do not have the affected product. 3) ICU Medical has some lots of unaffected product available today and is actively increasing the amount of available inventory. In the event specific product is unavailable, consider use of the non-spinning Spiros or the ChemoLock CSTD as alternatives. Please contact customer service for product availability. 4) Return affected product using the return label provided with this letter. Contact Stericycle at 1-888-871-7108 (MF, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product. 5) 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 Stericycle to obtain a response form. For further inquiries, please contact: Global Complaint Management, 1-844-654-7780 or ProductComplaintsPP@icumed.com; Customer Service, 1-866-829-9025, option 8 or, customerservice@icumed.com, (M-F, 8am-6pm CT) On 10/07/2020, the Medical Device Recall notice, with an expanded affected device scope, was sent to customers.