The Recall Desk
SevereFDA (Devices)·Z-1911-2020·Announced 2020-05-13

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.

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 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 →