Unomedical Silhouette Insulin Infusion Tubing Recalled for Detachment Risk
Unomedical As is recalling Silhouette and Silhouette Paradigm insulin infusion tubing due to a risk of tubing detachment. The recall affects approximately 9.8 million units 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 interruption of insulin delivery due to tubing detachment, which poses a risk of harm to patients, but the source does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Unomedical As has voluntarily recalled specific models of Silhouette and Silhouette Paradigm insulin infusion tubing. 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, which could interrupt insulin delivery.
The recall covers approximately 9,782,880 units of the affected tubing. The 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.
Consumers using these specific tubing models should check their product codes against the list provided by the FDA or the manufacturer. If the tubing is affected, users should contact Unomedical As or their healthcare provider for instructions on how to proceed. The FDA classifies this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin
- Manufacturer
- Unomedical As
- Affected units
- 9,782,880
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)
- 5031734
- 5034234
- 5034311
- 5035640
- 5036333
- 5037019
- 5037922
- 5037923
- 5039570
- 5040033
- 5040162
- 5040476
- 5041194
- 5043391
- 5043392
- 5046554
- 5047941
- 5048106
- 5049985
- 5051351
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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