ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 units of Y-Type Blood Sets because they were labeled as not containing DEHP, despite potentially containing small amounts.
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 with no reported injuries or illnesses, fitting the Moderate criteria for minor labeling errors.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 159" (404 cm) Y-Type Blood Sets. The specific product is a single-use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood. The recall involves Item Number Z2902 across multiple lot numbers, including 69-365-SJ, 69-707-SJ, and 70-196-SL.
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 is the primary reason for the corrective action.
The affected devices were distributed worldwide, including nationwide distribution in the United States to states such as 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 check their inventory for the specific item and lot numbers listed and stop using the affected devices.
The recalled product
- Product
- 159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, 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
- 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 Z2902
- Lot Number 69-365-SJ
- 69-707-SJ
- 70-196-SL
- 70-400-SL
- 70-759-SL
- 70-918-SL
- 70-952-SJ
- 71-189-Y1
- 71-562-Y1
- 71-669-Y1
- 71-861-Y1
- 73-604-HE
- 73-877-HE
- 74-014-JW
- 74-320-JW
- 74-463-JW
- 74-733-JW
- 75-262-JW
- 75-420-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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