Agency classClass IIOur severity:Severe FDA (Devices)·Z-0357-2017·Announced 2016-11-09

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: Unomedical As
Category: Medical Device — Insulin Infusion Accessories
Hazard: tubing-detachment
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

Distributed in 3 states:

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 →

Same manufacturer · Unomedical As

See all →

High
Unomedical Comfort 5+5 Insulin Infusion Pump Sets Recalled for Tubing Detachment
FDA (Devices) · 2016-11-09
High
Unomedical Recalls SureT G29 Insulin Infusion Pump Tubing Due to Detachment Risk
FDA (Devices) · 2016-11-09
High
Unomedical Recalls Insulin Infusion Sets Due to Tubing Detachment Risk
FDA (Devices) · 2016-11-09
High
Unomedical Silhouette Insulin Infusion Tubing Recalled for Detachment Risk
FDA (Devices) · 2016-11-09
High
Unomedical Comfort Infusion Sets Recalled for Tubing Detachment Risk
FDA (Devices) · 2016-11-09

Same hazard · tubing detachment