Recall Z-0588-2021— Becton Dickinson & Company

Name: FDA recall Z-0588-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-18

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2020-11-18, terminated 2024-02-15. It names one FDA 510(k) clearance: K021475. Product: 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.. 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..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2020-11-18
Terminated: 2024-02-15
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K021475 — BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SETBd·cleared 2002-07-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.