ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
ICU Medical is recalling IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source explicitly states that the defect 'may lead to serious adverse health consequences,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk scenarios warranting a Severe rating.
Plain-English summary
ICU Medical, Inc. is recalling 1,000 units of IV administration sets (REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211). The recall was initiated because the sets may contain a 15 drops/mL drop cannula instead of the intended 10 drops/mL drop cannula within the drip chamber.
The use of an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume, specifically under-delivery. This under-delivery of critical medication may lead to serious adverse health consequences for patients.
The affected product was distributed in the United States (excluding specific states listed in the source) and Canada. The source notes that REF numbers AH7117 and B30211 were not marketed or distributed within the US, and Lot # 4168832 was not distributed within the US. Healthcare providers and consumers should check their inventory for this specific product and discontinue use if found.
The recalled product
- Product
- REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 1,000
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 # 4168832 *Product not distributed within the US
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.
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