ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 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 DEHP content 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 147-inch Bifuse Blood Sets with 170 Micron Filters and Hand Pumps. The recall involves specific lots of the sterile, single-use blood tubing accessory with CLAVE Connector, which is 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 material composition information.
The affected products were distributed nationwide in the United States to 29 states and in Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Users should stop using the affected devices and contact ICU Medical for instructions on return or replacement.
The recalled product
- Product
- 147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as
- 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 (13)
- Item Number B5216
- Lot Number 3335222
- 3356780
- 3391845
- 3401803
- 3405384
- 3412076
- 3416485
- 3416486
- 3419516
- 3429619
- 3429620
- 3432660
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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