Health product recall

ChemoLock Port

Last updated

Summary

Product
ChemoLock Port
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Oncology Kit

14397348

CL3360

Oncology Kit

14369083

CL3967

Oncology Kit

14386090

CL3967

Oncology Kit

14391965

CL3967

Oncology Kit

14369087

CL4188

Chemolock

14391954

CL3900

ChemoLock Bag Spike

14419330

CL-10

ChemoLock Bag Spike

14385224

CL-17

ChemoLock

14384996

CL-35

ChemoLock

14391949

CL-35

ChemoLock

14407070

CL-35

ChemoLock

14379145

CL2100

Ext Set W/ChemoLock, Y Connector, Rotating Luer

14414091

CL3950

Ext Set W/ChemoLock, Y Connector, Rotating Luer

14409213

CL4118

Ext Set W/ChemoLock, Y Connector, Rotating Luer

14393168

CL3950

Ext Set W/ChemoLock, Y Connector, Rotating Luer

14393173

CL4118

ChemoLock Admin Set

14397353

CL3951

ChemoLock Admin Set

14418912

CL3951

ChemoLock Vial Spike

14391971

CL-70

ChemoLock Vial Spike

14395289

CL-70

ChemoLock Vial Spike

14379176

CL-70S

ChemoLock Vial Spike

14385352

CL-72

ChemoLock Vial Spike

14401250

CL-72

ChemoLock Vial Spike

14391976

CL-80

ChemoLock Vial Spike

14380121

CL-80S

ChemoLock Vial Spike

14391979

CL-80S

ChemoLock Vial Spike

14395313

CL-80S-5

ChemoLock Vial Spike

14407453

CL-82

Transfer Set

14376051

CL-33

Transfer Set

14400613

CL-33

Transfer Set

14400199

CL-34

Bag Spike, Clave

14386086

CL3955

Bag Spike, Clave

14407433

CL3955

Issue

ICU Medical has internally identified a lot-specific issue where the weld of the ChemoLock port was not functioning as intended due to a manufacturing issue. Impacted products include the standalone ChemoLock port, ChemoLock vial adapters, ChemoLock bag spikes, and ChemoLock administration sets that may include the ChemoLock port. The malfunctioning port weld may separate or break during use and potentially result in a leak.

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.
951 Calle Amanecer, San Clemente, California, United States, 92673
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78071

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