CLASS II Device recall · Reported 22 Aug 2018 · FDA Enforcement Report
(8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold recalled
ICU Medical de Mexico, S.A. de C.V is recalling (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating, distributed in 7 states. The recall was initiated on 1 Mar 2018 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-2797-2018
- FDA event ID
- 80460
- Recalling firm
- ICU Medical de Mexico, S.A. de C.V, Ejido Maneadero
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Mar 2018
- FDA classified
- 16 Aug 2018
- Reported
- 22 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 1 Mar 2018 | Recall initiated by company | |
| 16 Aug 2018 | Classified by FDA | +168 days |
| 22 Aug 2018 | 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
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
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
20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.
Where it was distributed
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
ArizonaMassachusettsNorth CarolinaOhioTexasVirginiaWashington
Questions about this recall
Is (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating recalled?
Yes. ICU Medical de Mexico, S.A. de C.V recalled (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating on 1 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-2797-2018.
Why was it recalled?
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Which lots are affected?
Item Number 011-AM3002. a. Lot Number 3326545, UDI Number (01) 1 0640619 09275 4 (17) 210901 (30) 50 (10) 3326545, Expiration Date 09/01/2021; b. Lot Number 3459161, UDI Number (01) 1 0840619 09275 4 (17) 220501 (30) 50 (10) 3459161, Expiration Date 05/01/2022
Where was it sold?
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
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.
More recalls from ICU Medical de Mexico, S.A. de C.V
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 6" Smallbore Ext Set w/6-Port NanoClave Manifold recalled | ICU Medical de Mexico, S.A. de C.V | Packaging Defects | 7 states |
| Device | CLASS II | (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold recalled | ICU Medical de Mexico, S.A. de C.V | Packaging Defects | 7 states |
| Device | CLASS II | 11" Smallbore Ext Set w/NanoClave recalled | ICU Medical de Mexico, S.A. de C.V | Packaging Defects | 7 states |
| Device | CLASS II | Proximale - (11") Smallbore Ext Set w/6-Port NanoClave recalled | ICU Medical de Mexico, S.A. de C.V | Packaging Defects | 7 states |
| Device | CLASS II | (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold recalled | ICU Medical de Mexico, S.A. de C.V | Sterility | 7 states |
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