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 CPT surgical convenience kits because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites. No illnesses have been reported.
AVID Medical is recalling Halyard OR Endovascular Tray surgical kits due to loose metal flakes that could detach from forceps and clamps and potentially enter the surgical site.
AVID Medical is recalling Halyard Open Heart Pack Main surgical kits because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site.
AVID Medical is recalling Halyard MANIFOLD CATH PACK medical convenience kits because sponge forceps and towel clamps may shed metal flakes that could contaminate surgical sites.
AVID Medical is recalling Halyard Upper Extremity Pack surgical kits because sponge forceps and towel clamps may shed small metal flakes. These flakes could enter a patient's surgical site, potentially causing local or foreign body reactions.
AVID Medical is recalling Halyard TOTAL KNEE kits because sponge forceps and towel clamps may have loose metal flakes that could detach and enter a patient's surgical site, causing local or foreign body reactions.
Halyard ENDOVASCULAR Model VMED008-02 surgical convenience kits are recalled due to potential loose metal flakes in sponge forceps and towel clamps. These flakes could enter a surgical site and cause local or foreign body reactions.
AVID Medical is recalling Halyard Anterior Hip Pack surgical kits because sponge forceps and towel clamps may have loose metal flakes that could detach, enter a patient's surgical site undetected, and cause local or foreign body reactions.
AVID Medical recalls Halyard Pacemaker Drape surgical instruments because metal flakes may detach from sponge forceps and towel clamps. Loose metal fragments could enter surgical sites undetected and cause local or foreign body reactions.
AVID Medical is recalling Halyard ORAL SURGERY HEAD medical convenience kits (Model SAMM029-15) due to potential loose metal flakes that could detach from forceps and clamps and enter the surgical site, posing risk of local or foreign body reactions.
AVID Medical is recalling Halyard Lower Extremity Pack surgical kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site undetected, potentially causing local or foreign body reactions.
AVID Medical is recalling Halyard BASIC PROCEDURE PACK surgical instrument kits because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site and cause local or foreign body reactions.
AVID Medical recalls Halyard Extremity Pack surgical instruments (model MMOK009-03) because small metal flakes may detach from sponge forceps and towel clamps and enter patients' surgical sites. No injuries have been reported.
AVID Medical is recalling Halyard ENT T and A Pack surgical kits nationwide due to loose metal flakes in sponge forceps and towel clamps that may contaminate surgical sites.
AVID Medical is recalling Halyard VA lumbar laminectomy surgical kits because sponge forceps and towel clamps may have loose metal flakes that could detach and enter a patient's surgical site.
AVID Medical is recalling Halyard KIT, SPINE surgical convenience kits due to loose metal flakes on sponge forceps and towel clamps. The flakes could detach and enter a patient's surgical site, potentially causing local or foreign body reactions.
AVID Medical is recalling 136 units of Halyard GYN TRAY surgical kits due to small loose metal flakes that could detach from sponge forceps and towel clamps. These metal fragments could enter a patient's surgical site undetected, causing local or foreign body reactions.
AVID Medical is recalling Halyard CPT EP PACK surgical convenience kits due to loose metal flakes on forceps and towel clamps. Detached metal flakes could enter surgical sites and potentially cause local tissue reactions or foreign body complications.
AVID Medical recalls Halyard FOOT ANKLE PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps that could enter surgical sites and cause local reactions.
AVID Medical is recalling Halyard SPINE surgical kits (Model EUOR004-02) due to loose metal flakes that may detach from sponge forceps and towel clamps. These flakes could potentially enter a patient's surgical site, causing local or foreign body reactions.
AVID Medical is recalling Halyard MINOR PACK medical kits because sponge forceps and towel clamps may shed loose metal fragments. These could enter surgical sites undetected, potentially causing local or foreign body reactions.
AVID Medical is recalling Halyard GENERAL SET UP PACK medical convenience kits nationwide due to sponge forceps and towel clamps that may shed small metal flakes into patients' surgical sites, risking local reactions and foreign body reactions.
AVID Medical is recalling Halyard GYN PAC medical convenience kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.