ICU Medical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1255-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Bag Hanger, Item No. 011-CL3511 sterile devices intended for the infusion and withdrawal of fluids.

Product Classification:

Class II

Date Initiated: February 25, 2016

Date Posted: April 6, 2016

Recall Number: Z-1255-2016

Event ID: 73391

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.

Status: Terminated

Product Quantity: 215 units

Code Information:

2860408 2903727 2938260 3048128 3072971

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,

Voluntary or Mandated:

Voluntary: Firm initiated