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Terminated

BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.

FDA Recall Z-1577-2013 · Posted 2013-06-21

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeMEG
Date Initiated2013-05-01
Date Terminated2013-09-25
Product Quantity1,326,000 units

Reason for Recall

There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.

Firm Action

Direct consignees were contacted by phone and email on 05/01/2013 and instructed to return the affected product. End users were mailed "Urgent: Product Recall" letters/Response Forms dated 05/01/2013. The notice advises customers of the product issue, identifies affected product and provides instructions on how to handle affected product.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution including US Nationwide and the countries of Canada and Suriname.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992734BECTON DICKINSON SYRINGEBd Becton Dickinson Vacutainer Systems Preanalytic · 1999-10-01

Official Source

View FDA Recall →

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

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