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Recall Observatory FDA recall evidence

Device product

30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. CL3528 sterile devices intended for the infusion and withdrawal of fluids.

Z-1260-2016

February 25, 2016

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 73391
Status
Terminated
Classification
Class II
Quantity
50 units
Official record key
device-enforcement:Z-1260-2016

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: 2770706

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.