ICU Medical, Inc.: 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.

Agency Publication Date: December 23, 2020

Affected Products

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

Lots: 4727479, 4784305

Product: 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros, REF: CH3353; 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Clamps, Spiros, REF: CH3367; 7" (18 cm) Appx 0.40 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, Spiros, 2 Clamps, REF: CH3379; 16" (41 cm) Appx 4

Lot: 4764635, 4887770, 4787215, 4877053, 4737148, 4850390, 4749863, 4849350, 4867377, 4741238, 4763286, 4774081, 4809085, 4877072, 4908343, 4719787, 4734320, 4741243, 4749867, 4854763, 4895575, 4849358, 4751063, 4763289, 4775529, 4724813, 4749880, 4854774, 4734335, 4757706, 4849376, 4764061, 4793547, 4749900, 4756873, 4777159, 4799805, 4902253, 4751908, 4793550, 4849389, 4896178, 4733498, 4764065, 4849391, 4719565, 4751101, 4790766, 4774117, 4736129, 4895706, 4858370

Lot Numbers:

4764635

Product: Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Closed Male Luer, REF: 066-CH2000S; SURPLUG ChemoAccess 5" (13cm) Bag Spike Adaptor with Closed Male Luer, REF: 066-CH3034; 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, Clave, Spiros w/Red Cap, Bag Hanger, REF: CH3762; 35" (89 cm) Appx 6.6 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Low Protein Binding Filter, Clave, Spiros w/Red Cap, Bag Hanger, REF: CH3763

Lots: 4605964, 4764534, 4903199, 4901115, 4849120, 4865839, 4895024, 4603209, 4866030

Product: 5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger, REF: CH3135; 14" (36 cm) Appx 4.8 ml, Bifuse Add-On Set w/Spiros w/Red Cap, Bag Spike, 3 Clamps (Blue, 2 White), Vented Cap, Drop-In Spiros w/Red Cap, REF: CH3156; 114" Bifuse Primary Set w/2 Spiros, Bag Spike, 2 20 Drop In-line Dri

Lots: 4726847 4764618 4749803 4882578 4719415 4858408 4763254 4799746 4909239 4763263 4807851 4849307 4711357 4734298 4784307 4877040 4603746 4751052 4809068 4719780 4887803 4902877 4741245 4773197 4793534 4853586 4603189 4749895 4800302 4749463 4751098 4775532 4853625 4877133 4902884 4726180 4751919 4763325 4742008 4763328 4877406 4902270 4589996 4741273 4751930 4764078 4849398 4894536 4742017 4784331 4894544 4774127 4719576 4787217 4908406 4752847 4866868 4908415 4854840 4853711 4894570 4759148 4605923 4784875 4800246 4807647 4866700 4590960 4802679 4889077

Product: 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Spiros, Closed Male Luer, REF: CH2000S; Spinning Spiros Closed Male Luer, 10 units, REF: CH2000S-10; Spinning Spiros Closed Male Luer, Red Cap, REF: CH2000S-C; Spiros, Closed Male Luer w/Red Cap, 10 Units, RES: CH2000SC-10; Spiros, Closed Male Luer w/Red Cap, 5 Units, REF: CH2000SC-5; Spinning Spiros Closed Male Luer, Pu

Lots: 4749745, 4764622, 4790769, 4806298, 4865663, 4712177, 4749754, 4757981, 4764633, 4793559, 4903194, 4726692, 4756786, 4800185, 4895432, 4726695, 4749730, 4757614, 4761878, 4784740, 4794303, 4895435, 4713514, 4713516, 4749750, 4749755, 4750947, 4750950, 4750952, 4757618, 4763178, 4806832, 4806838, 4849195, 4858381, 4895446, 4711932, 4726709, 4756789, 4761899, 4783763, 4858387, 4962299, 4726711, 4749767, 4774705, 4784757, 4795443, 4857778, 4727446, 4749771, 4711937, 4727450, 4882569, 4741999, 4757713, 4793544, 4908662, 4749745, 4764622, 4790769, 4865663, 4901210, 4749754, 4764633, 4603678, 4726692, 4756786, 4800185, 4895432, 4713516, 4749733, 4749750, 4749755, 4750947, 4750952, 4763174, 4763178, 4774701, 4774702, 4806838, 4849192, 4849195, 4857774, 4858382, 4895442, 4895446, 4896004, 4902104, 4726709, 4761899, 4727446, 4749771, 4774000, 4849201, 4877398, 4877399

Product: 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, Dro

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

Product: 3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinning Spiros, Red Cap, REF: CH2020; 30mL Syringe w/Spinning Spiros, Red Cap, REF: CH2030; 60mL Syringe w/Spinning Spiros, Red Cap, REF: CH2060; 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CH3011; 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrat

Lots: 4553702, 4605473, 4763191, 4775520, 4849205, 4549847, 4548779, 4572314, 4734247, 4763917, 4849208, 4741169, 4763921, 4560231, 4750962, 4549850, 4763200, 4734249, 4794307, 4806855, 4849220, 4861176, 4877472, 4605484, 4749780, 4795448, 4876942, 4719395, 4737146, 4764825, 4800210, 4866411, 4800214, 4734262, 4794308, 4795454, 4806862, 4849239, 4849248, 4849251, 4605504, 4719410, 4734273, 4757665, 4763982, 4799740, 4861174, 4605074, 4741282, 4751117, 4809117, 4877145, 4894538, 4557534, 4733509, 4741291, 4743763, 4774120, 4733512, 4865834, 4894550, 4573105, 4803126, 4808046, 4860027, 4806400, 4720476, 4724725, 4749443, 4786358, 4802674, 4849131, 4783296, 4730109, 4742662, 4759699, 4768019, 4794497, 4877852, 4897107, 4712378, 4749445, 4799839, 4806855, 4861176, 4719395, 4800210, 4764826, 4800214, 4719927, 4726732, 4733428, 4734262, 4741183, 4756802, 4763958, 4794308, 4794310, 4795452, 4806862, 4849230, 4849233, 4849239, 4719410, 4799839, 4859282

Product: Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Purple Cap, Bag Hanger, REF: 011-CH3185; 46 cm (18") Appx 7.4 ml, Trifuse Add-On Set w/2 Spiros w/Purple Caps, Bag Spike, 3 Clamps (Blue, 2 Red), Dry Spike Adapter, REF: 011-CH3266; 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Purple Cap, 20 Drop In-Line Drip Chamber, Bag Hanger, REF: 011-CH3446; 61 cm (24") Appx 8.2 ml, Bifuse Add-On Set

Lots: 4630846, 4848415, 4734764, 4734940, 4752044, 4742983, 4764957, 4878172, 4808952, 4867502, 4804800, 4854732, 4783273, 4773067, 4807223, 4800168, 4877026, 4752842, 4773432, 4764194, 4727034, 4847780, 4876626, 4548846, 4573171, 4867154, 4515064, 4574113, 4743010, 4773247, 4848995, 4740817, 4774162, 4877106, 4902461, 4711498, 4719930, 4740835, 4798726, 4866446, 4894490, 4727444, 4741918, 4778013, 4800251, 4806881, 4743840, 4734281, 4775528, 4799761, 4763261, 4774080, 4790739, 4749875, 4794599, 4802672, 4859281, 4718351, 4727042, 4741435, 4774258, 4866217, 4875126, 4899256, 4774269, 4777289, 4849437, 4853031, 4847272, 4882644 ,

Product: 31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3020; ChemoLock Port w/Spiros, Red Cap, REF: CL-35; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger, REF: CL3951; 40" (102 cm) Appx 7.7 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Drip Chamber, 0.2 Micron

Lots: 4867937, 4751234, 4799262, 4894789, 4787230, 4867947, 4897075, 4720480, 4735684, 4758456, 4775068, 4794504, 4860043, 4799897, 4787234, 4808045, 4860044 ,

Product: 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261; 44 cm(17 IN) Appx 2.9 ml,PUR YELLOW TRANS SET,ChemoClave,CK VLV,Spiros,PURPLE CAP, REF: 011-CH3568; Oncology Kit, 5 Gang Stopcock w/5 ChemoClave, Spiros w/Red Cap; 10cm Smallbore Bifuse Ext w/2 ChemoClave, Red Ring, BCV; 297cm Ext w/ChemoClave, REF: 011-CH3600; Oncology Kit, 5 Gang Stopcock w/5 ChemoClave, Spiros w/Red Cap; 10cm Smallbore Bifuse Ext, w/2 ChemoClav

Lots: 4784390, 4784404, 4865931, 4865006, 4590283, 4774210, 4865952, 4711264, 4605516, 4723103, 4882016, 4806569 ,

Product: Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx 1.5 ml, Bag Spike Adapter w/Spiros, Vented Cap, REF: IB-CH3034C

Lots: 4605119, 4726277, 4727007 ,

Product: Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260

Lots: 4741955, 4764030 ,

Product: 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795

Lots: 4758192, 4763891, 4794293, 4807842, 4849283, 4866670, 4877784, 4902534, 4909635 ,

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86426

Status: Active

Manufacturer: ICU Medical, Inc.

Manufactured In: United States

Units Affected: 13 products (19850; 33900; 55000; 1856578; 231250; 534764; 325; 217522; 88700; 4790; 37000; 900; 2900)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.