600 N. Field Drive Lake Forest, IL 60045

www.icumed.com

Page 1 of 7 MA2008-01 (1)

URGENT: MEDICAL DEVICE RECALL

1 September 2020

Dear Valued Customers: Director of Risk Management Director of Nursing Director of Materials Management

ICU Medical, Inc. is issuing this Urgent Medical Device Recall letter to notify you of a potential for leaks to occur with the Spinning Spiros Male Luer in certain lots. This urgent medical device recall letter details the issue and the required steps for you to perform.

Issue: ICU Medical has identified the potential for certain lots of the Spinning Spiros to exhibit leaks due to a molding defect. This information pertains to the spinning version of the Spiros only. The non-spinning version is not affected by this communication.

Potential Risk: 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. ICU Medical has received reports of leaks potentially related to this issue and has not received reports of permanent injury or death.

Affected Product: Our records indicate that you may have received some of the affected products, which were distributed in the United States between January 2020 and July 2020. The affected item and lot numbers are provided in Table 1.

Required Actions for Users:

1) Please discontinue the use and distribution of the affected product immediately. Check your inventory andquarantine all affected product at your facility.

2) Inform potential users of the product in your organization of this notification and complete the attached responseform. Return the completed response form to the fax number or e-mail address on the form, even if you do nothave the affected product.

3) ICU Medical has some lots of unaffected product available today and is actively increasing the amount of availableinventory. In the event specific product is unavailable, consider use of the non-spinning Spiros or the ChemoLockCSTD as alternatives. Please contact ICU Medical customer service for product availability.

4) Return affected product using the return label provided with this letter. Contact Stericycle at 1-888-871-7108 (M-F, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affectedproduct. The return labels are for single use only. Please do not reproduce. Please visit http://expertezlabel.comto request additional labels for returning affected product. To ensure proper and timely credit, follow theinstructions on the return label for returning product. Upon receipt of the completed response form and return ofthe affected product, ICU Medical will credit you for any product returned. You will only receive credit for productthat you return. NOTE: Credits for product purchased through distributor will be credited by the distributor.

5) If you have distributed the product further, immediately notify your accounts that received the product identifiedin the Affected Product / Table 1 sections of this notification and ask them to contact Stericycle at 1-888-871-7108(M-F, 8am-5pm ET) to obtain a response form.

4663_01_01AD_V1.1

600 N. Field Drive Lake Forest, IL 60045

www.icumed.com

Page 2 of 7 MA2008-01 (1)

Follow up Actions by ICU Medical: Please contact Customer Service using the information provided below for assistance reordering replacement product.

For further inquiries, please contact ICU Medical using the information provided below.

ICU Medical Contact Contact Information Areas of Support Global Complaint Management 1-844-654-7780 or

ProductComplaintsPP@icumed.com To report adverse events or product complaints

Customer Service 1-866-829-9025, option 8 orcustomerservice@icumed.com(M-F, 8am-6pm CT)

Additional information or assistance

The U.S. Food and Drug Administration (FDA) has been notified of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

ICU Medical is committed to patient safety and is focused on providing exceptional product reliability and the highest level of customer satisfaction. Thank you for your prompt support on this important matter. We appreciate your cooperation.

Sincerely,

Amy Giertych John Beard, MD Vice President, Global Regulatory Affairs Medical Director, Medical Affairs

Enclosures: Affected Product and Lot Numbers Response Form FAQs

4663_01_01BD_V1.1

600 N. Field Drive Lake Forest, IL 60045

www.icumed.com

Page 3 of 7 MA2008-01 (1)

Table 1: Affected Product and Lot Numbers

List Number Product Description Lot Number 20123-01 5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros 4726847 4764618

20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave® Drip Chamber, Spiros®, Bag Hanger

4749745 4764622 4790769 4806298 4865663

20130-01 Spinning Spiros® Closed Male Luer, Red Cap 4712177 4749754 4757981 4764633 4793559 4903194

20131-01 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros 4764635 4887770

AH2000S 4726922 4751105 4761825 4783375

CH2000S 4726692 4756786 4800185 4895432

CH2000S-10 Spinning Spiros® Closed Male Luer, 10 units 4726695 4749730 4757614 4761878 4784740 4794303 4895435

CH2000S-C Spinning Spiros® Closed Male Luer, Red Cap

4713514 4713516 4749750 4749755 4750947 4750950 4750952 4757618 4763178 4806832 4806838 4849195 4858381

CH2000SC-10 Spiros®, Closed Male Luer w/Red Cap, 10 Units 4726709 4756789 4761899 4783763 4858387

CH2000SC-5 Spiros®, Closed Male Luer w/Red Cap, 5 Units 4726711 4749767 4774705 4784757 4795443 4857778

CH2000S-PC Spinning Spiros® Closed Male Luer, Purple Cap 4727446 4749771 CH2000S-PCP Spiros, Purple Cap, Drop-In Priming Cap 4711937 4727450 4882569

CH2003 4553702 4605473 4763191 4775520 4849205

CH2005 4549847

CH2010 10mL Syringe w/Spinning Spiros®, Red Cap 4548779 4572314 4734247 4763917 4849208

CH2020 20mL Syringe w/Spinning Spiros®, Red Cap 4741169 4763921 CH2030 30mL Syringe w/Spinning Spiros®, Red Cap 4560231 4750962 CH2060 60mL Syringe w/Spinning Spiros, Red Cap 4549850 4763200

CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave® Drip Chamber, Spiros® w/Red Cap, Bag Hanger

4734249 4794307 4806855 4849220 4861176

CH3011-C 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave® Drip Chamber, Spiros® w/Red Cap, Hanger

4605484 4749780 4795448 4876942

CH3020 40 IN (102 cm) App 4.8 ml, Admin Set, 20 Drop, 2 Spiros, Bag Hanger 4719395 4737146 4764825 4800210 4866411

CH3033 14 IN (36 cm) App 4.8 ml, Bifuse Add-On Set, Spiros w/Red Cap, Bag Spike

4800214

4663_01_02AD_V1.1

600 N. Field Drive Lake Forest, IL 60045

www.icumed.com

Page 4 of 7 MA2008-01 (1)

List Number Product Description Lot Number 4734262 4794308 4795454 4806862 4849239 4849248 4849251

CH3035 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave®

Drip Chamber, Clave®, Spiros® 4749803 4882578

CH3128 30" (76 cm) Appx 5.9 ml, 20 Drop Admin Set w/Integrated

ChemoClave® Drip Chamber, 0.2 Micron Filter, Spiros® w/Red Cap, Hanger

4605504 4719410 4734273 4757665 4763982 4799740 4861174

CH3135 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrat 4719415 4858408

CH3156 Spike, 3 Clamps (Blue, 2 White), Vented Cap, Drop-In Spiros® w/Red Cap

4763254 4909239 4799746

CH3240 114" Bifuse Primary Set w/2 Spiros®, Bag Spike, 2 20 Drop In-line Drip Chamber, Clave®, Bag Hanger

4763263 4807851

CH3260 Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros 4741955 4764030

CH3286 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave® Drip Chamber, 1.2 Micron Filter, Spiros®, Bag Hanger

4727479 4784305

CH3290 18 IN (46 cm) Appx 2.9 ml, Add-On Set w/Spiros, Clave Spike, Clamp, Cap

4849307

CH3294 27" (69 cm) Appx 5.2 ml, Bifuse Add-On Set w/15 Drop Drip Chamber, Spiros® w/Red Cap, Check Valve, Vented Cap, Bag Hanger

4711357 4734298 4784307 4877040

CH3322 Secondary IV Oncology Kit 4603746 4751052 4809068 CH3327 30 IN (76 cm) Appx 1.8 ml) Ext Set w/2 Spiros, 2 Red Caps, Clamp 4719780

CH3330-C 31" (79 cm) Admin Set w/20 Drop Integrated Clave® Drip Chamber, Spiros®, Bag Hanger Drop-in Red Cap, 4 Units 4877053

CH3353 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros 4737148 4850390

CH3367 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 MicroClave®

Clear, 2 Clamps, Spiros® 4749863 4849350

CH3373 40" (102 cm) Appx 4.6 ml, Admin Set, 2 Spiros® w/2 Red Caps, 20 Drop In-Line Drip Chamber, 2 Bag Hangers

4887803 4902877

CH3379 7" (18 cm) Appx 0.40 ml, Smallbore Bifuse Ext Set w/2 MicroClave® Clear, Spiros®, 2 Clamps

4741238 4763286 4774081 4809085 4877072 4908343

CH3381 16" (41 cm) Appx 4.4 ml, Ext Set w/MicroClave®, 0.2 Micron Filter, Clave®, Spiros®, Clamp

4719787 4734320 4741243 4749867 4854763 4895575

CH3386 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave® Drip Chamber, Spiros® w/Drop-in Red Cap, 2 Hanger

4849358

CH3397 Oncology Kit w/Spiros®, Red Cap, Bag Spike w/Clave® Additive Port 4741245 4773197 4793534 4853586

CH3401 40" (102 cm) Appx 7.3 ml, 20 Drop Admin Set w/Integrated Clave® Drip Chamber, 0.2 Micron Filter, Spiros®, Hanger

4751063 4763289

CH3403 45" (114 cm) Appx 5.8 ml, Ext Set w/Red Cap, 2 Clamps

4603189

4663_01_02BD_V1.1

600 N. Field Drive Lake Forest, IL 60045

www.icumed.com

Page 5 of 7 MA2008-01 (1)

List Number Product Description Lot Number

CH3405 60" (152 cm) Appx 0.62 ml, Smallbore Ext Set w/MicroClave®, Clamp, Spiros® w/Red Cap 4775529

CH3453 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/Integrated Clave® Drip Chamber, Clave®, Spiros® w/Red Cap

4724813 4749880 4854774

CH3485 73" (185 cm) Appx 2.1 ml, Smallbore Ext Set w/MicroClave® Clear, Spiros®, Clamp 4734335 4757706 4849376

CH3507 Oncology Kit w/20" (51 cm) Ext Set w/MicroClave®, Graduated

Connector; Transfer Set w/Clave® Additive Port, Spiros®, Red Cap; 13mm Vial Spike w/Clave®

4749895

4800302

CH3515 Spinning Spiros Closed Male Luer w/Red Cap 4741999 4757713 4793544

CH3517 42" (107 cm) Appx 4.8 ml, 15 Drop Admin Set w/Spiros® w/Red Cap, Bag Hanger, Drop-In Priming Cap

4764061 4793547

CH3523 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/MicroClave® Clear, 2 Spiros®, 3 Clamps, Priming Cap

4749900 4756873 4777159 4799805 4902253

CH3533 74" (188 cm) Smallbore Ext Set w/MicroClave®, 0.2 Micron Low Protein Binding Filter, Spiros® w/Red Cap, Clamp

4751908 4793550 4896178

CH3538 74 IN (188 cm) Appx 0.92 ml, Smallbore Set, MicroClave, 1.2 Micron Fil, Spiros, Red Cap

4733498 4764065 4849391

CH3546 Oncology Kit w/Clave® Universal Vented Vial Spike; Spinning Spiros® w/Red Cap 4749463

CH3554 22" (56 cm) Add-On 150 ml Burette Set (MicroClave®, No Shut-Off), w/Spiros®, 2 Clamps, Vented Cap

4751098 4775532 4853625

CH3556 18" (46 cm) Appx 5.1 ml, Ext Set w/0.Clamp

4719565 4751101 4790766

CH3559 4.5 IN (11 cm) Appx 0.43 ml, Ext Set, Spiros w/Red Cap 4877133 CH3581 Oncology Kit w/Spinning Spiros®, C-Clip, Red Cap 4726180 4751919 4763325

CH3582 5 IN (13 cm) Appx 0.57 ml, Ext Set, Anti-Siphon Valve, Spiros 4742008 4763328 4877406 4902270

CH3589 Oncology Kit w/Spinning Spiros® w/Red Cap; C-Clip; Priming Cap 4589996 4741273 4751930 4849398 4894536

CH3603 e Ext Set w/MicroClave® Clear, 0.2 Micron Low Protein Binding Filter, Spiros® w/Red Cap, Clamp 4774117

CH3606 Oncology Kit w/60" (152 cm) Appx 2.3 ml, Smallbore Ext Set w/Spiros®,

Anti-Siphon Valve, ChemoClave®, Clamp, Rotating Luer; Double ChemoClave® Syringe Transfer Set; Spiros® w/Red Cap

4605074 4741282 4751117 4809117 4877145 4894538

CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave® (Purple, Green Rings), Spiros® w/Red Cap, 3 Clamps

4557534

CH3639 77" (196 cm) Appx. 9.4 ml, Admin Set w/2 Spiros® w/Red Cap, 20 Drop In-Line Drip Chamber, Bag Hanger

4742017 4784331 4894544

CH3642 86" (218 cm) Appx 10.4 ml, 20 Drop Admin Set w/Integrated ChemoClave® Drip Chamber, Spiros® w/Red Cap 4733509

CH3677 Oncology Kit w/40" (102 cm) Appx 4.7 ml, 20 Drop Admin Set

4741291

4663_01_03AD_V1.1

600 N. Field Drive Lake Forest, IL 60045

www.icumed.com

Page 6 of 7 MA2008-01 (1)

List Number Product Description Lot Number

CH3700 5.5" (14 cm) Appx 0.55 ml, Smallbore Trifuse Ext Set w/3 4774120

CH3703 50 IN (127 cm) Appx 6.4 ml, Ext Set w/ChemoClave, Spiros w/Red Cap, Clamp 4733512

CH3715 16 IN (41 cm) Appx 1.6 ml, Ext Set, ChemoClave, Spiros w/Red Cap 4865834 4894550

CH3770 w/Red Cap, 1.2 Micron Filter, 4 Clamps 4774127

CH3771 6.5 IN (17 cm) Appx 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros, Red Cap

4719576 4787217

CH3929 Oncology Kit, Ext w/Spiros, Grad Conn, 2 Vial Spikes w/Clave, Spinning Spiros

4573105 4803126 4808046 4860027

CH3932 Oncology Kit, w/Ext, MicroClave, Clave, Grad Conn, Transfer, Spiros, Vial Spike, Clave

4806400

CH3943 Oncology Kit, 12 IN Ext, Spiros, Graduated Adapter, 2 ChemoClave w/Vial Spike, Spiros

4720476 4724725 4749443 4786358 4802674 4849131

CH3944 Vented Vial Spike, 13mm

4783296

CH3946 Oncology Kit, 16 IN (41 cm) Ext Set, ChemoClave, Graduated Conn, 2 ChemoClave w/Vial Spike, Spiros

4730109 4742662 4759699 4768019 4794497 4877852 4897107

CH3949

Oncology Kit, 21" (53 cm) Appx 3.2 ml, Ext Set w/Spiros® w/Red Cap, Graduated Adapter; Locking Universal Vented Vial Spike

w/ChemoClave®; Closed Vial Spike, 13mm w/ChemoClave®; Spinning Spiros® w/Red Cap

4712378 4749445

CH4001 47" (119 cm) 50ml Diluent Set for Channel 2 w/20 Drop In-Line Drip Chamber, 2 Spiros®

4752847 4866868 4908415

CH4002 46" (117 cm) 50 ml, Diluent Set for Channel 2 w/20 Drop Drip Chamber, Spiros® 4799839

CH4009 47" (119 cm) 50 ml Diluent Set for Channel 2 w/Bag Spike w/MicroClave® Additive Port, Spiros® 4853711

CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated 4720479 4724743 4735699 4775051 4803047 4808098 4868079 4868080

CL3011T 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated 4735696

CL3020 Drop In-Line Drip Chamber, Spiros®, Bag Hanger, Drop-In Red Cap 4763384 4800367 4866943 4908482

CL3028 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated

Filter, Spiros®, Hanger, Drop-In Red Cap

4724700 4742639 4758414 4775030 4787228 4808060 4848204

CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated

Drop-In Red Cap

4712385 4724701

4663_01_03BD_V1.1

600 N. Field Drive Lake Forest, IL 60045

www.icumed.com

Page 7 of 7 MA2008-01 (1)

List Number Product Description Lot Number

CL3361 42" (107 cm) Appx 5.2 ml, Admin Set w/20 Drop In-Line Chamber, 4605106 4733557 4757782

4775514 4800370

CL3538 4724728 4765922 4867983

CL3929 Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated

Universal Vented Vial Spike; Bag Hanger

4724703 4749489

CL3931 8.5" (22 cm) Appx 1.0 ml, Ext Set 4803140 4878873

CL3932 7.5" (19 cm) Appx 1.1 ml, Bifu 4742641 4758385 4794501

CL3935 30 IN(76cm)APPX 2.1ml, EXT SET w/ChemoLock w/RED CAP, Spiros RED CAP

4720364 4752843 4799894 4850394 4866135

CL3941 Red Cap 4790865

CL3946 4735669 4742630 4758441 4764898 4787232 4848213 4867995

CL3948 Oncology Kit, ChemoLock Bag Spike w/Additive Port, Vented Cap, Spiros

4743901 4765927 4775070 4777973 4794503

CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set 4606697 4735662 4803124

4808069 4867961 4897098 4898098 4899830

CL3960T Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set 4573189 4606684 4749454

4756268 4803136 4808059 4848185

CL4100 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

4726940 4742091

CL4131 30" (76 cm) Appx 3.6 ml, Admin Set w/20 Drop In-Line Drip Chamber, 4749474

CL4151 Anti-Siphon Valve, Clamp, Y-ConnectLuer

4560357 4735675

Z7100 30" (76 cm) Appx 5.9 ml, 20 Drop Admin Set w/Integrated Clave® Drip Chamber, 0.2 Micron Filter, Spiros®, Hanger

4605923 4784875 4800246 4807647 4866700

4663_01_04AS_V1.1