ICU Medical Recalls IV Administration Sets with ChemoLock Port Leak Risk
ICU Medical is recalling specific IV administration sets because a connection may develop a leak. The sets are distributed in the US and several international locations.
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 (leak) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling 100 units of 74-inch (188cm) sterile IV administration sets with an integrated ChemoLock Port (Item No. 011-CL3341). The recall is due to a potential leak in the connection between the Drip Chamber or Bag Spike and the ChemoLock port.
The affected products are intended for the infusion and withdrawal of fluids. The issue has been identified in an isolated number of sets. The distribution pattern includes the United States (NV, OH, MO, CA, FL, VA, TX, NJ, CT, MI, AZ, MA, CO) and non-US locations (DE, AE, AT, PL, HU, SE, IL, JP, JO, SA).
Consumers and healthcare facilities should stop using the affected sets and contact ICU Medical for further instructions.
The recalled product
- Product
- 74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusion and withdrawal of fluids. Drip Chamber, Rotating Luer, Bag Hanger, Item No. 011-CL3341.
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 100
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)
- 2912285
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
Same manufacturer · ICU Medical, Inc.
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