Recall Z-2748-2017— Becton Dickinson & Company

Name: FDA recall Z-2748-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-16

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2016-09-16, terminated 2018-03-20. It names one FDA 510(k) clearance: K951254. Product: BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination. Reason: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2016-09-16
Terminated: 2018-03-20
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K951254 — SAFETYGLIDE NEEDLEBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1995-10-07

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 SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination

Reason for recall

BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

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