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Terminated

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

FDA Recall Z-2748-2017 · Posted None

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFMI
Date Initiated2016-09-16
Date Terminated2018-03-20
Product Quantity29,500 units

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.

Firm Action

BD sent recall letter/return response form on 9/16/2016.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K951254SAFETYGLIDE NEEDLEBd Becton Dickinson Vacutainer Systems Preanalytic · 1995-10-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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