ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood tubing sets because they were labeled as not containing DEHP, despite potentially containing small amounts.
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 minor labeling error regarding chemical composition (DEHP) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 120-inch Y-Type Blood Sets with 170 Micron Filters. These single-use, sterile devices are 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 labeling error affects the accuracy of the product's chemical composition information.
The affected products were distributed nationwide in the United States to 29 states and internationally to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. The specific item number is B9622, and the recall covers 16 specific lot numbers. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- 120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, 2 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 or venipuncture devices for
- Manufacturer
- ICU Medical, Inc.
- Hazard
- 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 (16)
- Item Number B9622
- Lot Number 3327623
- 3332856
- 3338452
- 3351761
- 3355549
- 3371150
- 3373269
- 3374329
- 3384355
- 3387646
- 3391948
- 3401837
- 3405445
- 3408966
- 3423453
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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