ICU Medical Recalls ChemLock I.V. Infusion Administration Sets
ICU Medical is recalling specific 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 hazard where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
ICU Medical, Inc. is recalling 19,250 units of 30-inch I.V. infusion administration sets with an integrated ChemoLock drip chamber. The affected devices are intended for the infusion and withdrawal of fluids.
The recall was initiated because an issue was identified 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 units were distributed in the United States (NV, OH, MO, CA, FL, VA, TX, NJ, CT, MI, AZ, MA, CO) and in several non-US countries including DE, AE, AT, PL, HU, SE, IL, JP, JO, and SA. Consumers and healthcare facilities should check their inventory for Item No. CL 3011 and stop using any affected units.
The recalled product
- Product
- 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.
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 19,250
Distribution
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 →Related recalls
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Similar recalls
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