Agency classClass IIOur severity:High FDA (Devices)·Z-1255-2016·Announced 2016-04-06

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

ICU Medical is recalling 215 I.V. infusion administration sets because a connection may develop a leak.

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 medical device with a potential leak, which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

ICU Medical, Inc. is recalling 215 units of 30-inch I.V. infusion administration sets with an integrated ChemoLock port. The specific item number is 011-CL3511. These sterile devices are intended for the infusion and withdrawal of fluids.

The recall was initiated because the company identified an issue with a connection in an isolated number of these sets. Specifically, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.

The affected products were distributed in the United States (NV, OH, MO, CA, FL, VA, TX, NJ, CT, MI, AZ, MA, CO) and internationally (DE, AE, AT, PL, HU, SE, IL, JP, JO, SA). The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units.

The recalled product

Product: 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.
Manufacturer: ICU Medical, Inc.
Category: Medical Device — I.V. Infusion Sets
Hazard: leak
Affected units: 215

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)

2860408 2903727 2938260 3048128 3072971

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 →

Same manufacturer · ICU Medical, Inc.

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Same hazard · leak