Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
6 IN (15 cm) Ext Set Recalled by ICU Medical, Inc. Due to Identification of a potential manufacturing defect on the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical, Inc. directly.
Affected Products
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, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
Quantity: Total of all products (Listed #1 thru 101) = 304735 units
Why Was This Recalled?
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ICU Medical, Inc.
ICU Medical, Inc. has 592 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report