ICU Medical Recalls NanoClave Sets Due to Potential Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets due to a potential manufacturing defect that may inhibit 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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (improper seal on an intravascular device) where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of 142-inch (361cm) MicroClave CLEAR intravascular administration sets equipped with a NanoClave connector. The recall involves a total of 304,735 units distributed worldwide, including the United States and countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.
The recall is being conducted due to a potential manufacturing defect on the internal surface of the NanoClave connector. This defect may inhibit a proper seal with the NanoClave spike. The affected lot numbers are 4573948, 4603380, 4711169, 4493653, 4536737, and 4733710.
Healthcare facilities and distributors should check their inventory for the specific lot numbers listed above. If the affected products are found, they should be removed from use and returned to ICU Medical, Inc. according to the recall instructions.
The recalled product
- Product
- 142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948;(01)10887709089393(17)250101(30)25(10)4603380; (01)10887709089393(17)250101(30)25(10)4711169…
- 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 (5)
- Lot Numbers:4573948
- 4603380
- 4711169
- 4493653
- 4536737 4733710.
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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