CLASS II ONGOING Device recall · Reported 19 May 2021 · FDA Enforcement Report
REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line recalled
ICU Medical is recalling REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line, distributed nationwide in the US. The recall was initiated on 16 Mar 2021 and the FDA has classified it as Class II.
Check your package
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-1579-2021
- FDA event ID
- 87703
- Recalling firm
- ICU Medical, San Clemente, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Mar 2021
- FDA classified
- 13 May 2021
- Reported
- 19 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 16 Mar 2021 | Recall initiated by company | |
| 13 May 2021 | Classified by FDA | +58 days |
| 19 May 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
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
REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Where it was distributed
Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom.
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Is REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line recalled?
Yes. ICU Medical recalled REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line on 16 Mar 2021. The recall is Class II and its status is Ongoing. Recall number Z-1579-2021.
Why was it recalled?
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Which lots are affected?
REF: CH3020 UDI: (01) 1 0840619 02400 7 (17) 260101 (30) 50 (10) 5125290 Lot Number: 5125290
Where was it sold?
Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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