ICU Medical Recalls Veterinary IV Administration Sets with Incorrect Drop Cannula
ICU Medical is recalling veterinary IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of medication.
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,' which aligns with the rubric criterion for Severe (4) involving significant injury reports or high-risk scenarios.
Plain-English summary
ICU Medical, Inc. is recalling 1,175 units of REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only. The recall involves Lot number 4173657. The product was distributed to various US states and Canada, although the source notes that specific REF numbers AH7117 and B30211 were not marketed or distributed within the US.
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. This discrepancy could result in inaccurate delivery of the intended infusion volume, specifically under-delivery. Under-delivery of critical medication may lead to serious adverse health consequences.
Veterinarians and veterinary facilities that have received this product should stop using the affected administration sets and contact ICU Medical for further instructions. Consumers should not use this product for human medical purposes, as it is labeled for veterinary use only.
The recalled product
- Product
- REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 1,175
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 4173657 *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.
See all 10 products in this recall →Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · medication under delivery
See all →- HighInfusion Pump Sets Recalled for Leakage and Medication Under-Delivery Risk
FDA (Devices) · 2021-10-06
- HighICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
FDA (Devices) · 2020-05-13
- SevereICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
FDA (Devices) · 2020-05-13
- SevereICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
FDA (Devices) · 2020-05-13
- SevereICU Medical Recalls 10 Drop Primary IV Sets Due to Cannula Error
FDA (Devices) · 2020-05-13
Similar recalls
- ModerateICU Medical Recalls Infusion Sets with Incorrect Spin Collars
FDA (Devices) · 2018-04-18
- HighICU Medical Recalls 30-inch IV Administration Sets Due to Molding Defect
FDA (Devices) · 2020-12-30
- HighICU Medical Recalls 7-inch Intravascular Administration Sets with Incorrect Spin Collar
FDA (Devices) · 2018-04-18
- HighICU Medical Recalls I.V. Infusion Sets with Potential Leak
FDA (Devices) · 2016-04-06
- ModerateICU Medical Recalls IV Administration Sets Due to Molding Defect
FDA (Devices) · 2021-05-19
- HighICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect
FDA (Devices) · 2020-10-28