Recall MonitorHealth Products
ChemoLock Port
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: ChemoLock Port
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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.