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. The recall covers devices distributed in the US and several international countries.
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 labeling error regarding DEHP content. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are classified as Moderate.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 84-inch 20 Drop Y-Type Blood Sets with 200 Micron Filters, Cylindrical Hand Pumps, Clave Connectors, and Rotating Luer fittings. These single-use, sterile, non-pyrogenic devices are intended as adjuncts 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. The affected items are identified by Item Number B9282 and specific lot numbers including 3331696, 3343698, 3344218, 3356703, 3367358, 3379230, 3381358, 3387630, 3391913, 3401825, 3416492, 3416493, 3423450, and 3429635.
The devices were distributed nationwide in the United States to 28 states and internationally to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and distributors should stop using the affected devices and contact ICU Medical for instructions on return or replacement.
The recalled product
- Product
- 84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave¿, 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 d
- 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 (15)
- Item Number B9282
- Lot Number 3331696
- 3343698
- 3344218
- 3356703
- 3367358
- 3379230
- 3381358
- 3387630
- 3391913
- 3401825
- 3416492
- 3416493
- 3423450
- 3429635
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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