ChemoLock ports with Spiros recalled over port weld separation risk
ICU Medical is recalling 2,000 ChemoLock Ports with Spiros and red cap because the port weld of the drug transfer device may separate or break during use and leak.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a weld that can break and leak on a drug transfer device is a hazard, and no injuries are reported.
Plain-English summary
The ICU Medical ChemoLock Port with Spiros and red cap, REF CL-35, is being recalled.
The port weld of the drug transfer device may separate or break during use and potentially result in a leak.
The recall covers 2,000 units from lots 14407070, 14384996 and 14391949. Distribution was worldwide, including nationwide in the United States and Canada. The FDA has classified the action as Class II.
The enforcement record describes the weld failure and reports no injuries. Because these ports are used to transfer hazardous drugs, facilities should quarantine affected lots and follow ICU Medical's instructions.
The recalled product
- Product
- ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 2,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot:14407070
- 14384996
- 14391949
- Distributed in Canada
Distribution
Part of a larger recall action
This product is one of 38 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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