ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling blood tubing accessories 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 hazard is a minor labeling error regarding DEHP content without reported injuries or illnesses, fitting the Moderate criteria for minor labeling errors.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 100" (254 cm) 20 Drop Y-Type Blood Sets with 200 Micron Filter, Hand Pump, 2 Clave, and Rotating Luer with Filter Cap. The affected devices are single-use, sterile, non-pyrogenic blood tubing accessories intended for needle-free withdrawal of blood. The recall involves Item Number K098-001 and Lot Numbers 3332425, 3364299, and 3396263.
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 constitutes a labeling discrepancy regarding the chemical composition of the medical device.
The affected units were distributed nationwide in the United States to specific states including AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, and WV. International distribution included Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and distributors should verify their inventory against the specific lot numbers and item number provided.
The recalled product
- Product
- 100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, 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 venipunctu
- 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 (4)
- Item Number K098-001
- Lot Number 3332425
- 3364299
- 3396263
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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