ChemoLock Port
Brand(s)
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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