ICU Medical Recalls Appx 1.7 ml Bag Spike Due to Molding Defect
ICU Medical is recalling 900 units of Appx 1.7 ml Bag Spike w/Integrated Clave due to a molding defect that may cause leaks in male luers.
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 defect that poses a risk of harm, including exposure to hazardous medications and blood, but the source text does not report any specific injuries or illnesses, 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 900 units of the Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros (REF: CH3260). The recall affects lots 4741955 and 4764030. The product was distributed nationwide in the United States and in numerous countries worldwide, including Italy, Belgium, the United Kingdom, Canada, Germany, and others.
The recall is due to a molding defect that may cause spinning versions of male luers to exhibit leaks. This fluid leakage may potentially cause a delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
Healthcare facilities and consumers should stop using the affected product and contact ICU Medical for further instructions or a return.
The recalled product
- Product
- Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 900
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 (2)
- Lots: 4741955
- 4764030
Distribution
Part of a larger recall action
This product is one of 13 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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