FDA (Devices) recall action 96731
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
AVID Medical is recalling Halyard CHRIST SUTURE KIT units due to a raw material issue in the needle coating that may cause silicone to be removed during use, potentially affecting surgical performance.
AVID Medical is recalling Halyard SUTURE PACK CABG Cardiovascular Procedure Convenience Kits due to a raw material defect in the surgical needle coating that may reduce needle performance or cause coating removal during use.
AVID Medical is recalling Halyard RAPIDES E-PACK Cardiovascular Procedure Convenience Kits due to a raw material defect in surgical needle coating that may cause diminished performance or coating removal during use.