ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific blood sets labeled as DEHP-free because they 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 labeling error regarding chemical composition (DEHP) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 143" (363 cm) 20 Drop Y-Type Blood Sets with 200 Micron Filters, Hand Pumps, and Clave Connectors. The affected devices are single-use, sterile, non-pyrogenic 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 labeling discrepancy affects the accuracy of the product's chemical composition information.
The affected units are identified by Item Number Z2819 and Lot Numbers 69-338-SJ and 72-415-HE. These products were distributed nationwide in the United States and in Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Users should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- 143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave¿, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct
- 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 Z2819
- Lot Number 69-338-SJ
- 72-415-HE
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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