ICU Medical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1259-2016)

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. 3.3 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.

Product Classification:

Class II

Date Initiated: February 25, 2016

Date Posted: April 6, 2016

Recall Number: Z-1259-2016

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: 7,500 units

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,

Voluntary or Mandated:

Voluntary: Firm initiated