ICU Medical Recalls Blood Sets with Inaccurate DEHP Labeling
ICU Medical is recalling specific blood tubing 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error regarding DEHP content, which fits the criteria for a moderate severity recall involving minor labeling errors or low-risk issues.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 125" (318 cm) Y-Type Blood Sets with 170 Micron Filter, Hand Pump, and CLAVE Connectors. The recall involves Item Number Z3417 across multiple lot numbers, including 69-204-SJ, 70-920-SL, and 71-002-HE.
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 discrepancy regarding the presence of a specific chemical in the medical device.
The affected devices 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. The devices were also distributed to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and consumers should stop using these specific blood sets and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 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 (12)
- Item Number Z3417
- Lot Number 69-204-SJ
- 70-920-SL
- 71-002-HE
- 72-138-HE
- 72-648-HE
- 73-397-HE
- 73-680-HE
- 74-012-JW
- 74-323-JW
- 75-175-JW
- 75-860-JW
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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