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SecureShield© for Dialysis 42" x 32" Scatter Reducing Drape

Barrier Technologies, LLC · Model SS-7200 · UDI-DI 10860004894664

KPY
10
510(k) clearances
71
Adverse events
2
Recalls
193
Facilities

Description

Outstanding protection during dialysis declotting procedures. Up to 80+% and 50% exposure reductions at hands and eyes, respectively. Shielding is easily adjustable as needed. Clinically proven to attenuate 95% of a 100kV direct beam. SecureShield Dialysis Access pads provide excellent protection for interventionalists and their teams during DADD procedures.

Recalls

DateFirmReason
2015-03-09GE HealthcareGE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not in
2014-05-02GE Healthcare, LLCGE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical lamp. This issue is

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.