CLASS II Device recall · Reported 15 Jan 2014 · FDA Enforcement Report
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip recalled
ICU Medical is recalling 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, distributed nationwide in the US. The recall was initiated on 24 Dec 2013 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-0702-2014
- FDA event ID
- 67166
- Recalling firm
- ICU Medical, San Clemente, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Dec 2013
- FDA classified
- 9 Jan 2014
- Reported
- 15 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 24 Dec 2013 | Recall initiated by company | |
| 9 Jan 2014 | Classified by FDA | +16 days |
| 15 Jan 2014 | 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 recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
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
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
Where it was distributed
Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.
Nationwide AlabamaCaliforniaGeorgiaHawaiiIllinoisIndianaKentuckyNorth CarolinaNew HampshireOhioTennesseeTexasUtahVermontWisconsin
Questions about this recall
Is 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip recalled?
Yes. ICU Medical recalled 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip on 24 Dec 2013. The recall is Class II and its status is Terminated. Recall number Z-0702-2014.
Why was it recalled?
ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
Which lots are affected?
B3303-T, Lot # 2791243.
Where was it sold?
Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.
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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