Unomedical Recalls SureT G29 Insulin Infusion Pump Tubing Due to Detachment Risk
Unomedical As is voluntarily recalling SureT G29 insulin infusion pump tubing because it may detach. The recall covers 4,748,000 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 and involves a risk of harm (tubing detachment) for a medical device used for insulin infusion, but the source text does not report specific injuries or hospitalizations.
Plain-English summary
Unomedical As is voluntarily recalling specific SureT G29 insulin infusion pump tubing products. The recall is due to a risk of tubing detachment. The affected products are used in combination with insulin infusion pumps for the continuous subcutaneous infusion of insulin.
The recall involves 4,748,000 units of SureT G29 tubing in various sizes (6mm, 8mm, and 10mm) and lengths (18", 23", and 32"). 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 by the firm on November 7, 2014, and was classified as Class II by the FDA. The recall status is currently terminated. Consumers should check their tubing lot numbers against the list provided in the official recall notice and contact Unomedical As for further instructions.
The recalled product
- Product
- SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used
- Manufacturer
- Unomedical As
- Hazard
- Affected units
- 4,748,000
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)
- 5038783
- 5040464
- 5042582
- 5042584
- 5043414
- 5043415
- 5046638
- 5046639
- 5047168
- 5049122
- 5052903
- 5052904
- 5056680
- 5057219
- 5057241
- 5057953
- 5060205
- 5061496
- 5063694
- 5064402
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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