Oncology transfer kits recalled over port weld separation risk
ICU Medical is recalling 600 Oncology Transfer Kits with ChemoClave and ChemoLock ports 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 Oncology Transfer Kit with ChemoClave and ChemoLock Port, Spiros with red cap and ChemoLock Port, REF CL4138, 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 600 units carrying UDI 10887709096131, from lot 14393176. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record describes the weld failure and reports no injuries. Because these kits are used to transfer hazardous drugs, facilities should quarantine the affected lot and follow ICU Medical's instructions.
The recalled product
- Product
- ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 600
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 (1)
- UDI:10887709096131/Lot: 14393176
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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