ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of 6-inch Intravascular Administration Sets because a manufacturing defect may prevent the NanoClave from sealing properly.
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 is classified as FDA Class II, and the defect poses a risk of harm to patients by potentially compromising the sterile seal of the intravascular device, although no specific injuries are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of 6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL Intravascular Administration Sets. The recall involves a total of 304,735 units distributed worldwide, including the United States and several international countries.
The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component within specific lots. This defect may inhibit a proper seal with the NanoClave spike. The affected lot numbers are 4584753 and 4559022.
Healthcare facilities and distributors should check their inventory for these specific lot numbers and stop using the affected products. Patients who have received these sets should contact their healthcare provider for guidance.
The recalled product
- Product
- 6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)10887709079877(17)250101(30)50(10)4559022. The Intravascular Administration Set is a single use…
- 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 (2)
- Lot Numbers:4584753
- 4559022.
Distribution
Part of a larger recall action
This product is one of 99 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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