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

(30") Appx, Admin Set, 2 Spiros w/Red Cap recalled by ICU Medical

ICU Medical is recalling (30") Appx, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron, 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: 4784390, 4784404, 4865931, 4865006, 4590283, 4774210, 4865952, 4711264, 4605516, 4723103, 4882016, 4806569 ,

Quantity recalled4790

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-0708-2021
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: Masks, Gloves & PPE

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

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 ChemoClave, Red Ring, BCV; 597 cm Ext w/ChemoClave, REF: 011-CH3601; Kit, 2 5 Gang Stopcocks w/5 MicroClave Clear, Spiros; 2 Smallbore Bifuse Ext Sets, 2 MicroClave Clear, Red Ring, Check Valve, RMLL; 2 Ext Sets, MicroClave Clear Clipped Together, RMLL, REF: 011-CH3610; Admin Set w/Clave, Spiros, REF: 011-CH3772; Admin Set w/Clave, Spiros, REF: 011-CH3773; Admin Set w/Clave, Spiros, REF: 011-CH3967; 76" (193 cm) 50 ml, Diluent Set for Channel 2 w/20 Drop Drip Chamber, Spiros, Drop-In Red Cap, REF: 011-CH4011

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

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	Spiros Closed Male Luer 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	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, 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

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