ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP. The devices were distributed in the US and several international countries.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard involves a labeling discrepancy regarding DEHP content, which is a minor labeling error rather than a high-risk pathogen or structural defect.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 135" (343 cm) Y-Type Blood Sets with 170 Micron Filter, Hand Pump, 2 Clave, Remv 4-Way Stopcock, Rotating Luer, and 2 Ext. The affected devices are sterile, single-use blood tubing accessories intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
The recall was initiated because some devices were labeled as "Does not contain DEHP" even though the product may contain small amounts of DEHP. The affected items are identified by Item Number B90041 and Lot Numbers 3332384 and 3374220.
The devices were distributed nationwide in the United States to specific states including AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, and WV. They were also distributed to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities should stop using the affected devices and contact ICU Medical for instructions on return or disposal.
The recalled product
- Product
- 135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or ven
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 160,016
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 (3)
- Item Number B90041
- Lot Number 3332384
- 3374220
Distribution
Part of a larger recall action
This product is one of 53 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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