Recall Z-0588-2021 ยท FMI Needle, Hypodermic, Single Lumen
Becton Dickinson & Company
BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.
| Date | Nov 18, 2020 |
| Status | Terminated |
| Reason | BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician. |
| Root cause | Under Investigation by firm |
| Action | Customers are provided with the following actions to take in the firm's recall notification letter: 1. Immediately review your inventory for the specific Catalog (Ref) and lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users within or outside your facility network to which you may have further distributed the affected product to ensure they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact note |
| Quantity | 1,430,000 |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of CA, CT, FL, IL, KY, MO, NJ, NY, OH, PA, PR, SC, TN, VA and the countries of Canada, China, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET Bd, Jul 19, 2002 |