ICU Medical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1257-2016)

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:

110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hanger, Item No. AHCL3300 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-1257-2016

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: 350 units

Code Information:

3114044 3118069 3124607 3128408 3183022

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