CLASS II Device recall · Reported 6 Apr 2016 · FDA Enforcement Report
30" Appx., Admin Set w/ 20 Drop Admin Set w/ Integrated recalled
ICU Medical is recalling 30" Appx., Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 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-1259-2016
- 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
- Other Medical Devices
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
30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 sterile devices intended for the infusion and withdrawal of fluids.
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 30" Appx., Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber recalled?
Yes. ICU Medical recalled 30" Appx., Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber on 25 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1259-2016.
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?
2775926 2812305 2817810 2822507 2869949 2906006 2935267 2956661 3000036 3021000 3022814 3050749 3093071 3106072 3112028 3113234 3116570 3122924 3124606 3128409 3146957 3154612 3158607 3160103 3172391 3179951 3182579
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.
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