ICU Medical Recalls Blood Administration Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood administration 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, but the source text identifies the issue as a labeling error regarding DEHP content without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 164-inch 20 Drop Y-Type Blood Admin Sets. The specific product is a single-use, sterile, non-pyrogenic blood tubing accessory with a CLAVE Connector, intended for needle-free withdrawal of blood. The recall involves Item Number MC33481 across multiple lot numbers.
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 discrepancy regarding the chemical composition of the device.
The affected units were distributed nationwide in the United States to 29 states, as well as 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
- 164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for
- 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 (10)
- Item Number MC33481
- Lot Number 3332863
- 3344272
- 3356773
- 3367490
- 3371297
- 3389253
- 3396288
- 3419674
- 3426437
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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