Unomedical Comfort Infusion Sets Recalled for Tubing Detachment Risk
Unomedical As is recalling 1.3 million Comfort infusion sets used with insulin pumps due to a risk of tubing detachment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (insulin delivery interruption) where the source text does not explicitly report injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Unomedical As has voluntarily recalled approximately 1,295,515 units of Comfort infusion sets. These medical devices are used in combination with insulin infusion pumps for the continuous subcutaneous infusion of insulin. The recall was initiated because the tubing may detach, which could interrupt the delivery of insulin to the patient.
The affected products were distributed worldwide, including in the United States (specifically California, Indiana, and Pennsylvania) and internationally to Canada, Korea, and Japan. The recall was initiated on November 7, 2014, and was terminated on November 16, 2016. The FDA classified this recall as Class II, indicating a situation where use of the product could cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific product codes listed in the official recall notice. If you have these infusion sets, you should stop using them and contact Unomedical As or the manufacturer for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 4
- Manufacturer
- Unomedical As
- Category
- Medical Device — Infusion Sets
- Affected units
- 1,295,515
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)
- 5021247
- 5021251
- 5021253
- 5029813
- 5031819
- 5031820
- 5031821
- 5031822
- 5031823
- 5032577
- 5032578
- 5033752
- 5033753
- 5033754
- 5033755
- 5034062
- 5034063
- 5034064
- 5034199
- 5034200
Distribution
Part of a larger recall action
This product is one of 6 recalled by Unomedical As 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 6 products in this recall →Related recalls
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