CLASS II Device recall · Reported 6 Apr 2016 · FDA Enforcement Report
74" approximately, 20 Drop Admin Set w/ Integrated recalled
ICU Medical is recalling 74" approximately, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV, distributed in 15 states. The recall was initiated on 25 Feb 2016 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-1254-2016
- FDA event ID
- 73391
- Recalling firm
- ICU Medical, San Clemente, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Feb 2016
- FDA classified
- 25 Mar 2016
- Reported
- 6 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Infusion Pumps
Timeline
| 25 Feb 2016 | Recall initiated by company | |
| 25 Mar 2016 | Classified by FDA | +29 days |
| 6 Apr 2016 | Published in enforcement report | +12 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 has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a 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
74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusion and withdrawal of fluids. Drip Chamber, Rotating Luer, Bag Hanger, Item No. 011-CL3341.
Where it was distributed
US: NV, OH, MO, CA, FL, VA, TX, NJ, CT, MI, AZ, MA, CO Non-US: DE, AE, AT, PL, HU, SE, IL, JP, JO, SA,
ArizonaCaliforniaColoradoConnecticutDelawareFloridaIllinoisMassachusettsMichiganMissouriNew JerseyNevadaOhioTexasVirginia
Questions about this recall
Is 74" approximately, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV recalled?
Yes. ICU Medical recalled 74" approximately, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV on 25 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1254-2016.
Why was it recalled?
ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.
Which lots are affected?
2912285
Where was it sold?
US: NV, OH, MO, CA, FL, VA, TX, NJ, CT, MI, AZ, MA, CO Non-US: DE, AE, AT, PL, HU, SE, IL, JP, JO, SA,
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
All 654| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hotline Fluid Warming Set, single use device recalled by ICU Medical | ICU Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump recalled by ICU Medical | ICU Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Plum Duo Infusion Pump recalled by ICU Medical | ICU Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Plum Duo Precision IV Pump recalled by ICU Medical | ICU Medical | Lead & Heavy Metals | Nationwide |
Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |