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:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

ICU Medical Inc.

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