ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 126-inch Y-Type 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 involves a minor labeling error regarding DEHP content, which fits the criteria for moderate severity involving low-risk contamination or labeling issues.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 126-inch (320 cm) Y-Type Blood Sets with 170 Micron Filters and Hand Pumps. The affected devices are single-use, sterile, non-pyrogenic blood tubing accessories intended for needle-free withdrawal of blood. The recall is due to a labeling error where the devices are marked as "Does not contain DEHP" even though the product may contain small amounts of DEHP.
The affected product is identified by Item Number Z3521 and Lot Number 74-350-JW. Distribution was worldwide, including nationwide distribution in the United States to specific states and international distribution to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa.
Consumers and healthcare facilities should stop using the affected blood sets and contact ICU Medical for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- 126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, 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 sets o
- 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 (2)
- Item Number Z3521
- Lot Number 74-350-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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