ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that 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, which typically corresponds to a moderate severity score. The hazard is a labeling error regarding DEHP content, which is a minor labeling issue without reported injuries or illnesses.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 88-inch (224 cm) Y-Type Blood Sets with 200 Micron Filter, Hand Pump, MicroClave, and Rotating Luer. The specific item number is B33828 and the lot number is 3381499. These 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 is a labeling error regarding the chemical composition of the device.
The affected units were distributed nationwide in the United States to 29 states and internationally to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and distributors should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Rotating Luer, 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 or venipuncture devices for need
- 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 B33828
- Lot Number 3381499
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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