Agency classClass IIOur severity:High FDA (Devices)·Z-1261-2016·Announced 2016-04-06

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

ICU Medical is recalling 400 units of I.V. infusion administration sets because the connection between the drip chamber and 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 involves a medical device with a structural defect (leak) that 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 where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling 400 units of 31-inch I.V. infusion administration sets with Integrated ChemoLock Port Drip Chamber, Spiros, and Bag Hanger (Item No. SL3011). The recall affects sterile devices intended for the infusion and withdrawal of fluids.

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 in an isolated number of units. This defect could compromise the integrity of the fluid delivery system.

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). Healthcare facilities and consumers should stop using these specific administration sets and contact ICU Medical for further instructions.

The recalled product

Product: 31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger, Item No. SL3011 sterile devices intended for the infusion and withdrawal of fluids.
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion Administration Sets
Hazard: leak
structural-defect
Affected units: 400

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)

3132625 3136286 3158761

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