ICU Medical Recalls ChemoLock IV Administration Sets Due to Leak Risk
ICU Medical is recalling specific IV 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 medical device with a risk of harm (leakage) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
ICU Medical, Inc. is recalling 50 units of 30-inch IV infusion administration sets (Item No. CL3528) that include an integrated ChemoLock port. The recall is due to a potential defect in the connection between the Drip Chamber or Bag Spike and the ChemoLock port, which has the potential for developing a leak.
The affected sterile devices are intended for the infusion and withdrawal of fluids. The recall covers units distributed in the United States (NV, OH, MO, CA, FL, VA, TX, NJ, CT, MI, AZ, MA, CO) and in non-US locations including DE, AE, AT, PL, HU, SE, IL, JP, JO, and SA.
Healthcare facilities and consumers should stop using these specific administration sets and contact ICU Medical for instructions on how to return or dispose of the affected units.
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. CL3528 sterile devices intended for the infusion and withdrawal of fluids.
- Manufacturer
- ICU Medical, Inc.
- Hazard
- 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)
- 2770706
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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