ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling
ICU Medical is recalling specific blood tubing sets labeled as DEHP-free because they may contain small amounts of the chemical.
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, but the specific hazard is a labeling error regarding DEHP content rather than a structural defect or reported injury, fitting the criteria for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 99" (251 cm) Y-Type Blood Sets with 170 Micron Filter, Hand Pump, 2 Clave, and Rotating Luer. The affected devices are single-use, sterile, non-pyrogenic accessories intended for needle-free withdrawal of blood. The recall involves Item Number Z1726, specifically Lot Numbers 69-705-SJ and 71-809-Y1.
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 labeling discrepancy constitutes a mislabeling issue regarding the chemical composition of the medical device.
The affected units 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 on return or disposal.
The recalled product
- Product
- 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, 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 devices for needle-
- 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 Z1726
- Lot Number 69-705-SJ
- 71-809-Y1
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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