CLASS II Device recall · Reported 28 Oct 2020 · FDA Enforcement Report
5" Appx, Smallbore Pressure Infusion recalled by ICU Medical
ICU Medical is recalling 5" Appx, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave, distributed nationwide in the US. The recall was initiated on 6 Jul 2020 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-0193-2021
- FDA event ID
- 86054
- Recalling firm
- ICU Medical, San Clemente, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jul 2020
- FDA classified
- 22 Oct 2020
- Reported
- 28 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 6 Jul 2020 | Recall initiated by company | |
| 22 Oct 2020 | Classified by FDA | +108 days |
| 28 Oct 2020 | 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
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062525(17)250101(30)50(10)4558455; (01)10887709062525(17)241201(30)50(10)4537168; (01)10887709062525(17)241201(30)50(10)4493389. The high pressure extension set is a device used as conduit tubing to deliver fluids from an ~f electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices.
Where it was distributed
Worldwide Distribution: US (nationwide): AL, AZ, CA, CO, DE, FL,GA,ID, IL,IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,NJ,NM,NV, NY, OH, OK, OR, PA,RI, TN, TX, UT, VA, WA, WI, and WV; and OUS countries of: Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.
Nationwide AlabamaArizonaCaliforniaColoradoDelawareFloridaGeorgiaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth CarolinaNebraska
Questions about this recall
Is 5" Appx, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave recalled?
Yes. ICU Medical recalled 5" Appx, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave on 6 Jul 2020. The recall is Class II and its status is Terminated. Recall number Z-0193-2021.
Why was it recalled?
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Which lots are affected?
Lot Numbers:4558455, 4537168, 4493389.
Where was it sold?
Worldwide Distribution: US (nationwide): AL, AZ, CA, CO, DE, FL,GA,ID, IL,IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,NJ,NM,NV, NY, OH, OK, OR, PA,RI, TN, TX, UT, VA, WA, WI, and WV; and OUS countries of: Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.
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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