The Recall Desk
HighFDA (Devices)·Z-1238-2023·Announced 2023-03-22

BD Insulin Syringes Recalled Due to Nonsterile Condition

BD Insulin Syringes (Catalog 329420) are being recalled due to nonsterile conditions that could expose patients to pathogenic microorganisms and increase infection risk. The recall affects 961,000 units distributed worldwide.

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 for a nonsterile medical device that presents a risk of local infection from pathogenic microorganisms. No illnesses or injuries have been reported, but the hazard presents a clear risk of harm.

Plain-English summary

BD Insulin Syringes with the BD Micro-Fine IV Needle (1ml, 12.7mm, 28G, Catalog Number 329420) are being recalled because some units were manufactured in a nonsterile condition. The nonsterile syringes potentially expose patients to pathogenic microorganisms and carry a risk of local infection.

Approximately 961,000 units have been distributed worldwide, including throughout the United States and to Chile, Colombia, Dominican Republic, Bahamas, Panama, Peru, Mexico, El Salvador, Malaysia, Philippines, Vietnam, Hong Kong, Taiwan, Thailand, and Canada. The affected lot number is 2038204 with an expiration date of April 30, 2027 (GTIN 00382903294206).

Patients who may have received these insulin syringes should contact their healthcare provider or pharmacy to determine if they received a unit from the affected lot. Do not use syringes from lot 2038204. Healthcare facilities should quarantine and not distribute units from this lot. Report any adverse events related to use of these syringes to the FDA's MedWatch program.

The recalled product

Product
BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale. Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329420
Manufacturer
Becton Dickinson & Company
Category
Medical Device — Injection Device
Hazard
  • nonsterile
  • 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 (1)

  • GTIN: (01) 00382903294206 Lot Number: 2038204 Exp. Date: 20270430

Distribution

Distributed nationwide across the United States.

Related recalls

Same category