ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of smallbore extension 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 involves a medical device with a defect that may compromise the integrity of the fluid administration system, posing a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling 304,735 units of 7-inch smallbore extension sets with MicroClave Clear, NanoClave, Clamp, and Rotating Luer. The affected products are identified by lot numbers 4718521 and 4735100. These single-use, pre-sterilized devices are used to administer fluids to a patient's vascular system.
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 affected products were distributed nationwide in the United States and in several countries including Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.
Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for instructions on return or replacement. Patients should consult their healthcare provider if they have received an infusion using these specific lots.
The recalled product
- Product
- 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10840619066014(17)250201(30)50(10)4718521;(01)10840619066014(17)250201(30)50(10)4735100. Administration sets and their…
- 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 (2)
- Lot Numbers:4718521
- 4735100.
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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