The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1257-2016·Announced 2016-04-06

ICU Medical Recalls I.V. Infusion Sets with Potential Leak

ICU Medical is recalling specific I.V. infusion administration sets because a connection may develop a leak. The recall affects 350 units distributed in the US and internationally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device leak) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling 350 units of 110-inch I.V. infusion administration sets with an integrated ChemoLock port. The affected product is identified by Item No. AHCL3300 and specific lot codes: 3114044, 3118069, 3124607, 3128408, and 3183022.

The recall was initiated because the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak. This issue affects an isolated number of the devices.

The affected units were distributed in the United States (NV, OH, MO, CA, FL, VA, TX, NJ, CT, MI, AZ, MA, CO) and in non-US locations including DE, AE, AT, PL, HU, SE, IL, JP, JO, and SA. Healthcare providers and consumers should stop using the affected sets and contact ICU Medical for instructions.

The recalled product

Product
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.
Manufacturer
ICU Medical, Inc.
Category
Medical Device — I.V. Infusion Sets
Hazard
Affected units
350

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 3114044 3118069 3124607 3128408 3183022

Distribution

Distributed in 14 states:

Part of a larger recall action

This product is one of 8 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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