ICU Medical Recalls ChemoLock IV Administration Sets Due to Leak Risk
ICU Medical is recalling specific IV infusion administration sets with ChemoLock ports because the 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 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 7,500 units of 30-inch IV infusion administration sets with integrated ChemoLock ports (Item No. CL3511). The recall involves sterile devices 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 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
- 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 sterile devices intended for the infusion and withdrawal of fluids.
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 7,500
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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