Recall Z-0204-2021— ICU Medical, Inc.

Name: FDA recall Z-0204-2021
Creator: U.S. Food and Drug Administration
Published: 2020-07-06

Class II · Terminated

Class II FDA medical device recall by ICU Medical, Inc., initiated 2020-07-06, terminated 2023-05-11. It names one FDA 510(k) clearance: K100576. Product: 6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080390(17)250101(30)50(10)4572792. The high pressure extension set is a device used as conduit tubing to deliver fluids from an ~f electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices.. Reason: 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..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-07-06
Terminated: 2023-05-11
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K100576 — HIGH PRESSURE SETS-400 PSIIcu Medical, Inc.·cleared 2010-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080390(17)250101(30)50(10)4572792. The high pressure extension set is a device used as conduit tubing to deliver fluids from an ~f electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.