AVID Medical, Inc. — Class I: Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
AVID Medical, Inc. has initiated a Class I recall of the Halyard 18G Single Shot Epi Tray (Model DPGE002-02) due to potential quality and sterility issues. The recall stems from Sodium Chloride ampules included in the kit that were subject to a prior recall by the component manufacturer, Spectra Medical.
This recall affects AVID Medical, Inc., healthcare providers using these specific epidural trays, and procurement teams responsible for sourcing sterile procedural kits.
A Class I designation indicates the FDA believes there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death. This situation highlights the regulatory risk inherent in kit assembly, where a sub-component recall necessitates a recall of the finished medical device combination. Regulatory and QA teams should note the critical importance of supplier monitoring and the downstream impact of component-level sterility failures.
Quality teams should immediately identify if the specified model number (DPGE002-02) is in inventory. Supply chain and procurement departments should review incoming materials for components sourced from Spectra Medical that may be subject to upstream recalls. Clinical departments must ensure affected trays are quarantined to prevent use.
Class I. Reason: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.. Product: Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;. Firm: AVID Medical, Inc. (Toano VA United States). Status: Ongoing.
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