Smallbore extension sets recalled because port weld may separate and leak
ICU Medical is recalling 200 60-inch smallbore extension sets with a ChemoLock port 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 60 inch (152 cm) approximately 1.2 mL smallbore extension set with ChemoLock port, clamp and Spiros with red cap, REF CL4173, 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 200 units carrying UDI 10887709123080, from lot 14351926. 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 sets are used to transfer hazardous drugs, facilities should quarantine the affected lot and follow ICU Medical's instructions.
The recalled product
- Product
- ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
- 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 (1)
- UDI:10887709123080/Lot: 14351926
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.
See all 38 products in this recall →Related recalls
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