ICU Medical Recalls NanoClave High Pressure Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave high pressure extension sets because a manufacturing defect may prevent a proper seal.
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 may compromise the sterile fluid pathway, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling 304,735 units of 7-inch NanoClave high pressure extension sets. The recall involves Lot Number 4603281, which was distributed nationwide in the United States and in several countries including Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.
The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component. This defect may inhibit a proper seal with the NanoClave spike. The device is used as conduit tubing to deliver fluids from an electronic or manual injector and may also serve as connector tubing to provide a sterile fluid pathway between two devices.
Healthcare facilities and distributors should stop using the affected product and contact ICU Medical for instructions on return or replacement. The agency has classified this as a Class II recall.
The recalled product
- Product
- 7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709071527(17)250101(30)50(10)4603281. The high pressure extension set is a device…
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
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)
- Lot Number: 4603281.
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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