ICU Medical Recalls Bifuse Blood Sets Due to DEHP Labeling Error
ICU Medical is recalling 160,016 Bifuse Blood Sets because they are labeled as DEHP-free but may contain small amounts of DEHP.
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, and the hazard involves a minor labeling error regarding DEHP content without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 125" (318 cm) Bifuse Blood Sets with 170 Micron Filter, Hand Pump, and MicroClave Clear connectors. The specific item number is MC330414 and the lot number is 3401939. These devices are single-use, sterile, non-pyrogenic blood tubing accessories intended 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. This constitutes a labeling discrepancy regarding the chemical composition of the device.
The affected products 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. Additionally, the products were distributed to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and distributors should stop using the affected lots and contact the manufacturer for instructions.
The recalled product
- Product
- 125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ Clear, Rotating Luer, 1 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 venipuncture
- 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 (2)
- Item Number MC330414
- Lot Number 3401939
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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