FDA (Devices) recall action 79162
The FDA (Devices) publishes a recall like this one as 23 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 23 pages.
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
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 12 TruCustom Laminectomy Kits because they may contain needles with loose polypropylene foreign material.
Avid Medical is recalling 120 TruCustom Lower Extremity convenience kits because they may contain needles with loose polypropylene foreign material.
Avid Medical is recalling 200 TruCustom DJ's Vascular/Neuro Tray kits because they may contain needles with loose polypropylene foreign material.
Avid Medical is recalling 90 TruCustom Pacemaker Pack convenience kits because they may contain loose polypropylene foreign material in the included needles.
Avid Medical is recalling 440 TruCustom Plastic Basin Packs because some kits contain needles with loose polypropylene foreign material.
Avid Medical is recalling 50 TruCustom DAVINCI PACK convenience kits because they may contain needles with loose polypropylene foreign material.
Avid Medical is recalling 24 knee arthroscopy kits because they may contain needles with loose polypropylene foreign material.
Avid Medical is recalling TruCustom GENERAL PACK kits because some contain needles with loose polypropylene foreign material above release specifications.
Avid Medical is recalling 44 TruCustom Minor Procedure kits because the included needles may contain loose polypropylene foreign material.
Avid Medical is recalling 30 TruCustom SPINE convenience kits because they may contain loose polypropylene foreign material in the needles.
Avid Medical is recalling 15 TruCustom Electro Physiology PK convenience kits because they may contain loose polypropylene foreign material in the needles.
Avid Medical is recalling 24 shoulder arthroscopy kits because they may contain loose polypropylene foreign material in the needles.
Avid Medical is recalling 46 TruCustom NEURO PK convenience kits because they may contain loose polypropylene foreign material in the needles.
Avid Medical is recalling 48 TruCustom Extremity Pack kits because they may contain loose polypropylene foreign material in the needles.
Avid Medical is recalling obstetrical convenience kits because some contain needles with loose polypropylene foreign material above release specifications.
Avid Medical is recalling 597 TruCustom Ortho Tray kits because they may contain needles with loose polypropylene foreign material.
Avid Medical is recalling 444 TruCustom CATH PACK kits because they may contain loose polypropylene foreign material in the needles.
Avid Medical is recalling 8 TruCustom Pacemaker Packs containing needles with loose polypropylene foreign material.
Avid Medical is recalling 354 TruCustom Heart Cath Tray kits because they may contain loose polypropylene foreign material in the included needles.
Avid Medical is recalling 160 GYN laparoscopy kits because they may contain needles with loose polypropylene foreign material.
Avid Medical is recalling 216 TruCustom Upper Extremity convenience kits because they may contain loose polypropylene foreign material in the needles.
Avid Medical is recalling 70 TruCustom Pacemaker Tray kits because they may contain needles with loose polypropylene foreign material.
Avid Medical is recalling 52 TruCustom PV Minor Pack convenience kits because they may contain needles with loose polypropylene foreign material.