ICU Medical Recalls 10 Drop Primary IV Sets Due to Cannula Error
ICU Medical is recalling 50 units of 10 Drop Primary IV Sets because they may contain 15 drops/mL cannulas, risking under-delivery of critical medications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect 'may lead to serious adverse health consequences' due to under-delivery of critical medication, which aligns with the rubric criterion for 'significant injury' or high-risk medical device defects.
Plain-English summary
ICU Medical, Inc. is recalling 50 units of REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way Stopcocks (1 Remv), Check Valve, Rotating Luer, 1 Ext, Sterile R. The affected lot number is 4169642. The product is a sterile intravenous administration set.
The recall is due to a potential manufacturing error where the IV administration sets may contain a 15 drops/mL drop cannula instead of the intended 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume, specifically under-delivery. This could lead to the under-delivery of critical medication, which may result in serious adverse health consequences.
The affected units were distributed to facilities in the United States (including AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY) and Canada. The source text notes that REF numbers AH7117 and B30211 were not marketed or distributed within the US. Healthcare facilities should check their inventory for this specific lot number and discontinue use of the affected sets.
The recalled product
- Product
- REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way Stopcocks (1 Remv), Check Valve, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709059108
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 50
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 (1)
- Lot number: 4169642
Distribution
Part of a larger recall action
This product is one of 10 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.
See all 10 products in this recall →Related recalls
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