Unomedical AC TenderLink Insulin Infusion Tubing Recalled for Detachment Risk
Unomedical As is recalling AC TenderLink insulin infusion tubing sets due to a risk of tubing detachment. The voluntary recall affects 653,280 units distributed in the US and internationally.
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 recall is classified as FDA Class II and involves a structural defect (tubing detachment) in a medical device used for insulin infusion, which meets the rubric criteria for a Severe rating.
Plain-English summary
Unomedical As is voluntarily recalling specific lots of AC TenderLink and AC TenderLink I insulin infusion tubing sets. The recall was initiated because the tubing may detach, which is a defect in the product's structural integrity. The affected products are used in combination with insulin infusion pumps for the continuous subcutaneous infusion of insulin.
The recall covers 653,280 units of the device. These 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 health consequences.
Consumers who have these specific products should stop using them and contact Unomedical As for instructions on how to return or replace the tubing. The recall was initiated by the firm and is now terminated.
The recalled product
- Product
- AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination wit
- Manufacturer
- Unomedical As
- Hazard
- Affected units
- 653,280
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)
- 5032433
- 5033654
- 5037164
- 5040419
- 5044362
- 5046682
- 5051308
- 5053298
- 5058508
- 5061927
- 5062202
- 5065546
- 5069297
- 5072252
- 5075118
- 5044359
- 5053289
- 5061929
- 5032436
- 5033657
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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