ICU Medical Recalls Blood Tubing Accessories Due to DEHP Labeling Error
ICU Medical is recalling specific blood tubing accessories 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: This is a Class II recall involving a labeling error regarding DEHP content. The rubric classifies minor labeling errors and voluntary precautionary recalls as Moderate severity.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 120-inch 10 Drop Primary Sets with CLAVE Connectors. The affected devices are single-use, sterile, non-pyrogenic blood tubing accessories intended for use as an adjunct to blood tubing sets or venipuncture devices 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 is a labeling error regarding the chemical composition of the device.
The affected products are distributed nationwide in the United States and in Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. The specific item number is Z4089, and the affected lot numbers are 69-717-SJ, 70-260-SL, 73-197-HE, and 74-725-JW. Healthcare facilities and distributors should stop using these specific lots and contact the manufacturer for further instructions.
The recalled product
- Product
- 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, 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 se
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Blood Tubing
- 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 (5)
- Item Number Z4089
- Lot Number 69-717-SJ
- 70-260-SL
- 73-197-HE
- 74-725-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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