Graduated adapter extension sets recalled over port weld separation risk
ICU Medical is recalling 5,700 7.5-inch extension sets with a ChemoLock port and graduated adapter because the port weld 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 7.5 inch (19 cm) approximately 1.5 mL extension set with ChemoLock port, clamp and graduated adapter, REF CL3967, 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 5,700 units from lots 14369083, 14386090 and 14391965. 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 sets are used to transfer hazardous drugs, facilities should quarantine affected lots and follow ICU Medical's instructions.
The recalled product
- Product
- ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 5,700
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)
- Lot:14369083 14386090 14391965
- 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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