Oncology kits recalled because a port weld may separate and leak
ICU Medical is recalling 200 Oncology Kits with two ChemoLock components because the port weld of the drug transfer device may separate or break during use and leak.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 2 ChemoLock components, REF CL4188, is being recalled. The kit contains a 13mm closed vial spike with ChemoLock port, a ChemoLock bag spike, an extension set with ChemoLock port, a clamp and a graduated adapter.
The port weld of the drug transfer device may separate or break during use and potentially result in a leak.
The recall covers 200 units from lot 14369087. 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 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 Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 200
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:14369087
- 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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