BD Ultra-Fine Insulin Syringes Recalled Due to Nonsterile Condition
Becton Dickinson is recalling BD Ultra-Fine Insulin Syringes (Catalog Number 326719) due to a nonsterile condition that could expose patients to pathogenic microorganisms and local infection. Approximately 80,500 units distributed worldwide are affected.
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: FDA Class II recall involving a nonsterile medical device designed for insulin administration. The nonsterile condition poses a risk of infection from pathogenic microorganisms. No illnesses or injuries are reported in the source material, but the risk-of-harm nature of the product warrants a High severity classification per the rubric.
Plain-English summary
Becton Dickinson & Company is recalling BD Ultra-Fine Insulin Syringes (1mL, 12.7mm, 29G, Catalog Number 326719) due to a nonsterile condition. These syringes are designed for administering insulin in diabetes treatment. The nonsterile condition creates a potential risk of exposure to pathogenic microorganisms and local infection.
The recall involves Lot Number 2031581, totaling approximately 80,500 units distributed worldwide. Distribution includes the United States and the following countries: Chile, Colombia, Dominican Republic, Bahamas, Panama, Peru, Mexico, El Salvador, Malaysia, Philippines, Vietnam, Hong Kong, Taiwan, Thailand, and Canada.
The recalled product
- Product
- BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326719
- Manufacturer
- Becton Dickinson & Company
- Hazard
- nonsterile
- pathogenic-contamination
- infection-risk
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 (2)
- GTIN: N/A Lot Number: 2031581
- Exp. Date: 2031581
Distribution
Distributed nationwide across the United States.
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