ICU Medical Flush Kits Recalled for Stopcock Molding Defect
ICU Medical is recalling Flush Kits with 3 Way Off Stopcocks due to a molding defect that may occlude side ports.
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 defect that could lead to a risk of harm (occluded ports) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
ICU Medical, Inc. is recalling Flush Kits with 3 Way Off Stopcocks (Part Number AG8137, 510(k) K052865, Lot number 2466161). The recall was initiated due to a molding defect in the high pressure stopcock.
The defect may cause a small percentage of the side ports to become totally occluded. The product was distributed nationwide.
Healthcare facilities should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
- Manufacturer
- ICU Medical, Inc.
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)
- Part Number AG8137 510(k) K052865 Lot number 2466161
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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.
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