On Aug. 18, 2015, the FDA issued a safety alert for BD’s 3mL and 5mL general use plastic syringes related to reduced drug potency. BD’s 3mL and 5mL plastic syringes are not to be used for drug storage, but rather are indicated as fluid aspiration and injection devices. BD syringes are safe when used as indicated.
The safety alert is relevant to a small percentage of customers, such as drug compounders, who are storing certain types of medications in the syringes. Decreased potency has only been reported in general use plastic syringes, primarily in 3mL and 5mL sizes, and appears to be related to BD’s alternate supplier for the plunger’s stopper. These syringes are not intended or FDA-cleared for drug storage.
BD shares the FDA’s vigilance to educate healthcare providers about the proper use of its products to ensure safe medication practices and the safety of patients. On July 31, BD reached out to customers to inform them of potential issues with drug storage. BD will continue to diligently investigate the matter while transparently communicating relevant information in a timely manner.
This safety alert does not pertain to BD prefilled, prefillable, heparin flush, saline flush or insulin syringes.
UPDATE: All of BD’s 3mL and 5mL general use syringe configurations that are commercially available in the US, Canada and Europe are once again manufactured with stoppers sourced solely from BD’s primary stopper supplier.
September 8, 2015 FDA Alert
September 1, 2015 Letter to US Syringe Customers
August 18, 2015 FDA Alert
Technical Update to July 31, 2015 Letter to US Syringe Customers
July 31, 2015 Letter to US Syringe Customers
Search Alternate Stopper Catalog/Lot Information
You may enter multiple Lot Numbers to determine if the lots were produced using the alternate stopper, or you may enter a Catalog No. to see all lots produced using the alternate stopper.
Most BD Catalog numbers are six digits and most BD Lot numbers are seven digits. If your Catalog or Lot Number is shorter, longer, or made up of a combination of letters and numbers, please refer to the files listed below for "Non-traditional Catalogs and Lots". The search tool will not return results for these atypical catalog and lot number formats.
U.S. Alternate Stopper Quick Reference Guide
Instructions for identifying CATALOG and LOT numbers
Non-traditional Catalogs and Lots (sorted by LOT)
Non-traditional Catalogs and Lots (sorted by CATALOG)