ICU Medical Recalls High Pressure Stopcocks Due to Molding Defect
ICU Medical is recalling 4,625 High Pressure Stopcocks because a molding defect may cause side ports to become totally occluded.
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 (occlusion of IV ports) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 4,625 units of High Pressure Stopcock (3-Way, Luer Lock, Off) intended for IV use. The recall was initiated due to a molding defect that could cause a small percentage of the side ports to become totally occluded.
The affected products are identified by Part Number 423530401, 510(k) K052865, and Lot Numbers 2432974, 2441508, 2448504, and 2455568. The products were distributed nationwide.
Healthcare facilities and consumers should stop using the affected stopcocks and contact ICU Medical for further instructions.
The recalled product
- Product
- High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — IV Equipment
- Hazard
- Affected units
- 4,625
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 (4)
- Part Number 423530401 510(k) K052865 Lot#s: 2432974
- 2441508
- 2448504
- 2455568
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.
See all 4 products in this recall →Related recalls
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