Unomedical Recalls Insulin Infusion Sets Due to Tubing Detachment Risk
Unomedical As is voluntarily recalling 664,000 Contact Detach 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 (tubing detachment interrupting insulin delivery) without reported injuries or fatalities in the source text, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Unomedical As is voluntarily recalling approximately 664,000 units of Contact Detach 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 include various sizes of Contact Detach and Infusion Set, Contact Detach, specifically the 8mm 23-inch, 8mm 43-inch, 6mm 23-inch, 6mm 32-inch, 8mm 32-inch, and 8mm 23-inch models. The recall covers products distributed in the United States (including California, Indiana, and Pennsylvania) as well as internationally to Canada, Korea, and Japan.
The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences. The recall was initiated by the firm in November 2014 and was terminated in November 2016. Patients using these infusion sets should contact their healthcare provider or the manufacturer for instructions on how to replace the affected devices.
The recalled product
- Product
- Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in
- Manufacturer
- Unomedical As
- Affected units
- 664,000
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 (20)
- 5031810
- 5034061
- 5034232
- 5035097
- 5036348
- 5038182
- 5038183
- 5038184
- 5038185
- 5038186
- 5038187
- 5038188
- 5040990
- 5040991
- 5040992
- 5041073
- 5041074
- 5045147
- 5045148
- 5047241
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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