Agency classClass IIOur severity:High FDA (Devices)·Z-1256-2016·Announced 2016-04-06

ICU Medical Recalls IV Infusion Sets with Potential ChemoLock Port Leak

ICU Medical is recalling specific IV infusion administration sets because the connection between the drip chamber or bag spike and the ChemoLock port 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 is classified as FDA Class II, and the hazard involves a potential leak in a medical device used for fluid infusion, which poses a risk of harm even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling 50 units of 30-inch IV infusion administration sets with an integrated ChemoLock port, 0.2 micron filter, and hanger (Item No. 011-CL3528). The recall was initiated after the company identified an issue with a connection in an isolated number of these devices.

The specific defect involves the connection between the Drip Chamber or Bag Spike and the ChemoLock port, which has the potential for developing a leak. These sterile devices are intended for the infusion and withdrawal of fluids.

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 specify the exact actions consumers or healthcare providers should take, such as whether to stop using the product or contact the manufacturer, but the recall indicates a potential safety issue with the device's integrity.

The recalled product

Product: 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. 011-CL3528 sterile devices intended for the infusion and withdrawal of fluids.
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Infusion Sets
Hazard: leak
device-integrity
Affected units: 50

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)

2938262

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