Health product recall

Microclave Clear Sets

Brand(s)
Last updated

Summary

Product
Microclave Clear Sets
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Double Connector

5724498

MC100-DC

Pressure Infusion Ext Set W/Microclave Clear, Clamp, Rotating Luer

5736601
5789780

MC33213

ifuse Microclave Ext Set

5725526
5725559

MC33691
MC33636

Trifuse Microclave Ext Set

5772352
5753321
5754294
5762576
5744883
5664461

MC33769
MC33547
MC33687

Bifuse Ext Set W/2 Microclave Clear, Clamp, Rotating Luer

5772085
5692316
5677797

MC330476
K7059-001

Ext Set W/Remv Microclave Clear, Clamp, Rotating Luer

5772609
5679662
5772630
5772606

MC3325

Clear Microclave Connector

5777730
5716994
5771950
5786565
5716993
5755652
5716989
5716990
5739482
5771956
5716986
5757425

MC100
K7047-001

Microclave Ext Set

5772640
5800914
5757503
5754104
5800955
5754132
5757061
5753823
5772173
5762312
5788745
5763303
5772198
5772548

MC33481
MC33688
MC33634
MC33324
MC33122
MC33467
MC33492

Issue

ICU Medical has identified the potential for a manufacturing defect within specific lots of Microclave clear sets, which may result in a visible gap between the Microclave clear connectors top and bottom housings. Inadequate connection between the Microclave clear connectors top and bottom housings may potentially cause fluid leak, blood loss, air ingress, or contamination.

Recall start date: July 27, 2022

Additional information

Details
Original published date: 2022-08-11
Alert / recall type
Health product recall
Category
Health product - Medical device - General hospital and personal use
Companies

ICU Medical Inc.

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64449