—#118354

Product

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

FDA product code: MEG — Syringe, Antistick
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K992734
Affected lot / code info: Catalog/Lot Number: REF#305950 Lot 2132028 and Lot 2159189

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

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

Timeline

Recall initiated: 2013-05-01
Posted by FDA: 2013-06-21
Terminated: 2013-09-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118354. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.