Tandem T:slim Insulin Pump Cartridges Recalled for Leak Risk
Tandem Diabetes Care is recalling specific lots of T:slim insulin cartridges due to a risk of leaking, which could cause incorrect insulin delivery.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 source text explicitly states that the defect can lead to a 'serious adverse event,' which aligns with the rubric criterion for 'significant injury' reports or risks, warranting a Severe classification.
Plain-English summary
Tandem Diabetes Care Inc is recalling specific lots of insulin cartridges used with the T:slim Insulin Delivery System. The recall involves 12,807 boxes (10 packs) distributed nationwide in the United States. The specific lot numbers affected are listed in the agency's structured data.
The recall is being issued because the insulin cartridges may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event.
Consumers should check their insulin cartridges against the list of affected lot numbers. If a cartridge is affected, users should stop using it and contact Tandem Diabetes Care for instructions on replacement or refund.
The recalled product
- Product
- T:slim Insulin Delivery System Insulin Infusion Pump
- Manufacturer
- Tandem Diabetes Care Inc
- Hazard
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)
- Lot Numbers: M000857
- M001414
- M001454
- M001963
- M002028
- M000869
- M001415
- M001455
- M001964
- M002029
- M001344
- M001416
- M001456
- M001973
- M002030
- M001345
- M001417
- M001457
- M001974
- M002082
Distribution
Distributed nationwide across the United States.
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