FDA (Devices) recall action 95515
The FDA (Devices) publishes a recall like this one as 73 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 73 pages.
Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
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 SPECIALS PACK medical convenience kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
AVID Medical, Inc. is recalling Halyard EP PACK medical convenience kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
AVID Medical is recalling 42 Halyard Laparoscopy Trays because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
AVID Medical is recalling 411 Heart Cath Lab Kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
AVID Medical, Inc. is recalling Halyard SAMMC-N pacemaker convenience kits because sponge forceps and towel clamps may shed metal flakes that could enter a patient's surgical site.
AVID Medical, Inc. is recalling Halyard C Section Bundles because small metal flakes may detach from sponge forceps and towel clamps, posing a risk of foreign body reactions.
AVID Medical is recalling 81 units of Halyard CPT PEDS ADULT CH PACK surgical kits because sponge forceps and towel clamps may shed metal flakes.
AVID Medical, Inc. is recalling 137 Halyard MINOR PDS medical convenience kits because sponge forceps and towel clamps may release metal flakes into surgical sites.
AVID Medical is recalling Halyard Line Insertion Packs because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
AVID Medical, Inc. is recalling the Halyard Interventional Tray medical kits because sponge forceps and towel clamps may shed small metal flakes. These loose flakes could enter a patient's surgical site undetected, causing local or foreign body reactions.
AVID Medical is recalling Halyard angiography pack surgical instruments due to loose metal flakes that could detach and enter a patient's surgical site, potentially causing foreign body reactions.
AVID Medical recalls Halyard D & C surgical convenience kits due to potential metal flakes that could detach from forceps and clamps. Affected lot 1596759 was distributed nationwide.
AVID Medical is recalling Halyard EP TRAY surgical convenience kits due to sponge forceps and towel clamps that may shed small metal flakes. These flakes could enter surgical sites, potentially causing local or foreign body reactions.
AVID Medical is recalling Halyard C Section Pack surgical kits due to loose metal flakes on sponge forceps and towel clamps. These flakes may enter a surgical site and cause local reactions or foreign body complications.
Halyard abdominal procedure surgical kits may contain loose metal flakes in forceps and clamps that could enter the surgical site. Affected kits have lot number 1590888.
AVID Medical is recalling Halyard PACK MINOR surgical kits due to loose metal flakes that may detach from forceps and towel clamps. These flakes could potentially enter a patient's surgical site, causing local or foreign body reactions.
Halyard AORTA PACK surgical kits are recalled because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.
AVID Medical recalls Halyard Urology Laparotomy Pack surgical instruments (Model SAMM023-13, Lot 1595070) due to loose metal flakes that could detach from forceps and clamps, potentially entering surgical sites and causing foreign body reactions.
AVID Medical is recalling Halyard PACEMAKER PK medical convenience kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.
AVID Medical is recalling Halyard Pacemaker Instrument Packs (Model VAPX040-01) because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site during procedures.
AVID Medical is recalling the Halyard MAJOR VAGINAL GYN PACK due to sponge forceps and towel clamps that may shed loose metal flakes. These flakes could enter a surgical site undetected, causing local reactions or foreign body reactions.
AVID Medical is recalling Halyard ENT surgical convenience kits due to potential metal flakes from forceps and clamps that could enter a patient's surgical site. Metal flakes may cause local or foreign body reactions during surgery.
AVID Medical recalls Halyard EYE PLASTIC TRAY medical kits due to loose metal flakes in sponge forceps and towel clamps. Metal flakes may contaminate surgical sites, potentially causing foreign body reactions or local tissue damage.
AVID Medical is recalling Halyard ANGIO ARTERIOGRAM PACK surgical kits due to metal flakes that may detach from forceps and clamps. Metal fragments could enter a patient's surgical site and cause local or foreign body reactions.
AVID Medical is recalling Halyard VAG hysterectomy instrument bundles due to loose metal flakes on surgical instruments that could contaminate surgical sites.