Allison Medical recalls InControl insulin syringes for incorrect needle gauge labeling
Allison Medical is recalling 150,000 InControl insulin syringes distributed in Texas due to incorrect package labeling of needle gauge. The mislabeled packages may lead patients to unknowingly select the wrong needle size.
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: This is an FDA Class II medical device recall for incorrect labeling on insulin syringes. No illnesses or injuries have been reported. However, incorrect needle gauge labeling on insulin injection devices poses a direct risk to patient safety, as it may result in selection and use of the wrong needle size. This meets the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Allison Medical, Inc. is recalling InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC because retail packages are incorrectly labeled regarding needle gauge specifications.
The recalled product consists of 1,500 boxes containing 150,000 syringes distributed in Texas. The affected lot number is 00041220791484 with an expiration date of March 31, 2022.
The incorrect labeling means the package information does not accurately reflect the needle gauge of the syringes contained within.
Patients with affected syringes should stop using them and contact Allison Medical, Inc. or their healthcare provider for guidance on obtaining replacement products.
The recalled product
- Product
- InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC
- Manufacturer
- Allison Medical, Inc.
- Category
- Medical Device
- Hazard
- mislabeling
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 (1)
- UDI/Lot/Expiration: 00041220791484/ 170407/ 2022-03-31
Distribution
Distribution scope not specified by the agency.
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