Oncology kits with vented vial spike recalled over port weld failure
ICU Medical is recalling 1,100 Oncology Kits containing a ChemoLock Universal Vented Vial Spike because the port weld of the drug transfer device may separate or break 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 Kit with 31 inch (79 cm) 20 drop administration set with integrated ChemoLock port drip chamber, Spiros, ChemoLock, ChemoLock Universal Vented Vial Spike and bag hanger, REF CL3929, 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 1,100 units carrying UDI 10887709076768, from lots 14400216 and 14416769. 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 affected lots and follow ICU Medical's instructions.
The recalled product
- Product
- ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 1,100
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:10887709076768/Lot: 14400216
- 14416769
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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