CLASS II ONGOING Device recall · Reported 30 Dec 2020 · FDA Enforcement Report

Spiros Closed Male Luer w/Red Cap recalled by ICU Medical

ICU Medical is recalling Spiros Closed Male Luer w/Red Cap, distributed nationwide in the US. The recall was initiated on 31 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 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 ,

Quantity recalled217522

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0706-2021
FDA event ID: 86426
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Ongoing
Recall initiated: 31 Aug 2020
FDA classified: 23 Dec 2020
Reported: 30 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

31 Aug 2020	Recall initiated by company
23 Dec 2020	Classified by FDA	+114 days
30 Dec 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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 w/Bag Spike, Spiros w/Purple Cap, 3 Clamps (1 Blue, 2 White), Check Valve, Dry Spike Adapter, REF: 011-CH3729; 25 UNITS of Spiros CLOSED MALE LUER, REF: 011-H2457; Appx 1.0 ml, Adattatore per Pompa con Spiros, REF: 011-H2629; 179 cm (70") Appx 11.5 ml, PUR Ambr. Deflussore con Spiros, Camera, BCV, Y-Clave e LL Gir., REF: 011-H2776; 180 cm (71IN)APPX 11.5ml,PUR AMBR,Spiros,CAMERA,REG.FLUSSO,BCV,Y-Clave, REF: 011-H2864-HSR; 181cm(71 IN)APPX11.6ml,PUR DEFLUSSORE,Spiros,20 DROP IN LINE,BCV,Clave, REF: 011-H2904; 38 cm (15 IN) APPX 2.9 ml, TRIFUSE EXT SET, 3 MicroClave, Spiros, PURPLE CAP, REF: 011-H3449; 42cm(16.5 IN)APPX 2.6ml,PUR TRANSFER SET,Clave ADDITIVE PORT,BCV,Spiros, REF: 011-H3597; 41cm(16 IN)APPX 2.9ml,PUR SET PERFORATORE,Clave,VALVOLA,Spiros, REF: 011-H3628; 41cm(16 IN)APPX 3.1ml,SET AMBRATO,PERFORATORE,Clave,VALVOLA,Spiros, REF: 011-H3629; 42cm(16.5 IN)APPX 5.6ml,SET,PERFORATORE,Clave,FILTRO,VALVOLA,Spiros, REF: 011-H3630; 109 cm(43 IN) APPX 7.2 ml,KIT,EXT SET W/Spiros,STOPCOCK,5 Clave,4-GANG STOPCOCK, REF: 011-MC330632; 2 Ext Sets w/5-Gang Stopcock, 9 Clave, Spiros, Stopcock, REF: 011-MC33242; Kit for multiple transfers, REF: 011-N1000; Kit per il riempimento pompe elastomeriche con SPIROS / Kit for elastomeric pump priming with SPIROS, REF: 011-N1000-P2; APPX 2.3ml, ZYTO-VERBINDUNGSLEITUNG (ZYTO-CONNECTING LINE), REF: 011-N1664SP; Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros, REF: 034-H2629; Spinning Spiros Closed Male Luer, Red Cap (No Flange), REF: CH2000S-NR; 15" (38 cm) Appx 5.2 ml, Bifuse Add-On Set w/Bag Spike, Spiros, 3 Clamps (Blue, 2 White), Dry Spike Adapter, REF: CH3187; 14" (36 cm) Appx 8.0 ml, Quinfuse Add-On Set w/4 Spiros, Bag Spike, 5 Clamps (Blue, 4 Red), Dry Spike Adapter, REF: CH3225; 20" (51 cm) Appx 9.5 ml, Quadfuse Add-On Set w/3 Spiros, Bag Spike, 4 Clamps (Blue, 3 Red), Dry Spike Adapter, REF: CH3226; 16" (41 cm) Appx 6.3 ml, Trifuse Add-On Set w/2 Spiros, Bag Spike, 3 Clamps (Blue, 2 Red), Dry Spike Adapter, REF: CH3227; 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros, REF: CH3235; 28" (71 cm) Appx 5.1 ml, Add On Set w/Clave Spike, Spiros, Clamp, REF: CH3354; 16cm(6 IN)APPX 2.4ml,SET,MicroClave Clear,STOPCOCK,DROP-IN ADD-ON,Spiros, REF CH3411: APPX 1.9 ml,13 cm (5 IN),BAG SPIKE,Spiros,ACCESS DEVICE w/Clave, REF: CH3502; 60 (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3603; Spinning Spiros Closed Male Luer, REF: K7040-001; APPX 0.76ml, 4-WAY STOPCOCK w/2 Clave, VIAL ADAPTER, 3 Spiros, REF: K7052-001; ZYTOmed Verab.-Set Onko II lichtschutz, REF: SN1205AG; ZYTOmed - Verabreichungs-Set Onko III lichtgesch¿tzt, REF: SN1206A; Conector macho cerrado Spinning Spiros, tapon purpura, REF: 034-CH2000S-PC

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Which lots are affected?

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 ,

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

12 other products · FDA event 86426

This product is part of a recall event; the main page for the event is 30" Appx, 20 Drop Admin Set w/Integrated ChemoLock Drip recalled.

Reported	Class	Recall	Company	Reason	Where
30 Dec 2020	CLASS II	30" Appx, 20 Drop Admin Set w/Integrated ChemoLock Drip recalled	ICU Medical	Packaging Defects	Nationwide
30 Dec 2020	CLASS II	Appx, 10 Drop Blood Set, 170 Micron Filter, Spiros recalled	ICU Medical	Packaging Defects	Nationwide
30 Dec 2020	CLASS II	Appx, 20 Drop Admin Set, Spiros recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
30 Dec 2020	CLASS II	30" Appx 20 Drop Admin Set w/Integrated Clave Drip Chamber recalled	ICU Medical	Packaging Defects	Nationwide
30 Dec 2020	CLASS II	Appx, Bag Spike Adapter, Spiros recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
30 Dec 2020	CLASS II	Appx Bag Spike w/Integrated Clave, 2 Drop-In Spiros recalled	ICU Medical	Packaging Defects	Nationwide
30 Dec 2020	CLASS II	(30") Appx, Admin Set, 2 Spiros w/Red Cap recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
30 Dec 2020	CLASS II	30" Appx, 20 Drop Admin Set w/Integrated Clave Drip Chamber recalled	ICU Medical	Packaging Defects	Nationwide
30 Dec 2020	CLASS II	Spinning Spiros Closed Male Luer, Red Cap recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
30 Dec 2020	CLASS II	31" Appx, Admin Set w/20 Drop Integrated ChemoLock Drip recalled	ICU Medical	Packaging Defects	Nationwide
30 Dec 2020	CLASS II	Syringe w/Spinning Spiros, Red Cap recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
30 Dec 2020	CLASS II	Spinning Spiros, Closed Male Luer recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide

More recalls from ICU Medical

All 654

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29 Jul 2026Device	CLASS II	Hotline Fluid Warming Set, single use device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
17 Jun 2026Device	CLASS II	Plum Solo Precision IV Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Infusion Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Precision IV Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide

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