Cypress Medical Recalls McKesson Insulin Syringes Due to Suction Defect
Cypress Medical Products LLC is recalling 400 cases of McKesson Insulin Syringes because a small hole impedes liquid suction.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (impeded suction) without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Cypress Medical Products LLC is recalling 400 cases of McKesson Insulin Syringes, 0.3mL 31GX5/16, Item Number 102-SN310C31516P. The affected product is identified by Lot Code KSH0603 and was distributed nationwide in the United States.
The recall was initiated because a small hole at the end of the syringe is impeding the suction of liquid. This defect may affect the proper function of the syringe when used for the injection of U-100 insulin.
Consumers who have this specific lot of syringes should stop using them and contact Cypress Medical Products LLC for further instructions or a replacement.
The recalled product
- Product
- McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
- Manufacturer
- Cypress Medical Products LLC
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 400
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)
- Lot Code: KSH0603
Distribution
Distributed nationwide across the United States.
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