ChemoLock vial spikes recalled because port weld may separate and leak
ICU Medical is recalling 53,050 ChemoLock 20mm 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 Vial Spike, 20mm, REF CL-80S, 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 53,050 units carrying UDI 10887709069593, from lots 14379182, 14391979, 14395300, 14401254 and 14380121. 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 Vial Spike, 20mm REF: CL-80S
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 53,050
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 (5)
- UDI:10887709069593/Lot:14379182
- 14391979
- 14395300
- 14401254
- 14380121
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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