ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific blood tubing sets because they are labeled as not containing DEHP, even though they may contain small amounts of the chemical.
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 due to a labeling error regarding DEHP content. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity level.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 112-inch 20 Drop Y-Type Blood Sets with 200 Micron Filters, Hand Pumps, 3 Clave Connectors, and Rotating Luer fittings. The recall is due to a labeling error where some devices are marked as "Does not contain DEHP" despite potentially containing small amounts of DEHP.
The affected products are single-use, sterile, non-pyrogenic devices intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood. The recall covers specific lot numbers including 69-334-SJ, 70-212-SL, and others listed in the agency record. Distribution was worldwide, including nationwide distribution in the United States and to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa.
No illnesses or injuries have been reported in connection with this recall. The FDA has classified this as a Class II recall, indicating that use of or exposure to the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- 112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 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 devices fo
- 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 (20)
- Item Number Z1440
- Lot Number 69-334-SJ
- 70-212-SL
- 70-913-SL
- 70-937-SJ
- 71-660-Y1
- 72-392-HE
- 72-620-HE
- 72-905-HE
- 73-158-HE
- 73-389-HE
- 73-625-HE
- 73-995-HE
- 74-006-JW
- 74-307-JW
- 74-453-JW
- 74-714-JW
- 75-430-JW
- 75-656-JW
- 75-834-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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