Unomedical Comfort 5+5 Insulin Infusion Pump Sets Recalled for Tubing Detachment
Unomedical As is recalling 22,114 Comfort 5+5 insulin infusion pump sets because the tubing may detach. The recall covers products distributed in the US and internationally.
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. The hazard involves the detachment of insulin infusion tubing, which poses a risk of harm to patients relying on continuous insulin delivery, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Unomedical As is voluntarily recalling 22,114 units of Comfort 5+5 Pack insulin infusion pump sets. The affected products include specific configurations with 110cm or 60cm tubes and 17mm or 13mm cannulas. These products are used in combination with insulin infusion pumps for the continuous subcutaneous infusion of insulin.
The recall was initiated because the tubing may detach. The products were distributed worldwide, including in the United States (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.
Consumers who have these products should stop using them and contact Unomedical As for instructions on how to return the product or obtain a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 The products are used
- Manufacturer
- Unomedical As
- Affected units
- 22,114
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 (11)
- 5048997
- 5048998
- 5048999
- 5052118
- 5052332
- 5052333
- 5052334
- 5063721
- 5066962
- 5066963
- 5066964
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.
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