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Recall Observatory FDA recall evidence

Device product

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.

Z-1259-2016

February 25, 2016

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 73391
Status
Terminated
Classification
Class II
Quantity
7,500 units
Official record key
device-enforcement:Z-1259-2016

Official wording

Reason: 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.

Code information: 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

Distribution pattern: 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,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.