ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk
ICU Medical is recalling 13,800 MicroClave T-Connectors because potential connection separation issues could lead to leakage.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (leakage) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling 13,800 units of 108" (274 cm) Transfer Sets with MicroClave T-Connectors. The affected products are identified by Item No. B33326 and specific lot numbers including 2997915, 2997919, 2997920, 2998568, 2998569, 3001232, 3001233, 3001234, 3004257, 3015880, 3015881, 3019519, and 3020159.
The recall was initiated because the MicroClave T-Connectors have potential connection separation issues that could lead to leakage. This is classified as an FDA Class II recall.
The affected products were distributed nationwide in the United States, specifically in South Carolina, North Carolina, Minnesota, Connecticut, Kentucky, Maryland, Florida, Virginia, and Tennessee. Healthcare facilities and consumers should stop using the affected products and contact ICU Medical for further instructions.
The recalled product
- Product
- 108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
- Affected units
- 13,800
Distribution
Part of a larger recall action
This product is one of 8 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 8 products in this recall →Related recalls
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