ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product 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 source text identifies the issue as a labeling error regarding DEHP content without reporting any illnesses or injuries. This aligns with the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 115" (292 cm) Y-Type Blood Sets with 170 Micron Filter, Hand Pump, and CLAVE Connector. The recall involves specific lots of Item Number Z3172, including lot numbers 69-859-JW, 71-573-Y1, 72-148-HE, 73-408-HE, 74-103-JW, 75-322-JW, 75-645-JW, and 76-107-SJ.
The reason for the recall is that some devices were labeled as "Does not contain DEHP" even though the product may contain small amounts of DEHP. This is a labeling error regarding the chemical composition of the sterile, non-pyrogenic medical device.
The affected products were distributed nationwide in the United States to 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 and consumers should check their inventory for the specific item and lot numbers listed and stop using the affected devices.
The recalled product
- Product
- 115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Connector w/Pre-Pierced Port, Luer Slip, 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
- 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 (9)
- Item Number Z3172
- Lot Number 69-859-JW
- 71-573-Y1
- 72-148-HE
- 73-408-HE
- 74-103-JW
- 75-322-JW
- 75-645-JW
- 76-107-SJ
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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