Universal vented vial spikes recalled over port weld separation risk
ICU Medical is recalling 16,850 ChemoLock Universal Vented Vial Spikes 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 Universal Vented Vial Spike, REF CL-70, 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 16,850 units carrying UDI 10887709057095, from lots 14391971 and 14395289. 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 spikes are used to transfer hazardous drugs, facilities should quarantine affected lots and follow ICU Medical's instructions.
The recalled product
- Product
- ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 16,850
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 (2)
- UDI:10887709057095/Lot: 14391971
- 14395289
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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