ICU Medical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1258-2016)

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 Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerestories 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-1258-2016

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: 19,250 units

Code Information:

2603990 2638178 2648080 2650789 2651575 2707143 2758814 2775922 2807999 2812304 2822505 2935268 2959788 2981443 2996455 3004510 3004872 3014970 3021774 3031244 3036751 3042661 3050748 3062734 3066394 3070408 3090587 3093069 3095818 3099253 3104787 3106886 3113237 3116568 3124603 3128411 3150731 3160102 3168416 3175643 3179949 3184510

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