GM Helix Acqua Implant, Article Number: 140.984
Straumann USA
Class I - Dangerous
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,589 recalls
GM Helix Acqua Implant, Article Number: 140.985
Straumann USA
Class I - Dangerous
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
There were reports of an increase in reactive negative controls and false positive results.
Due to mislabeling of products
Due to mislabeling of products
MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
Nipro Renal Soultions USA
Class I - Dangerous
Potential for the presence of visible foreign matter.
Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Class I - Dangerous
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Class I - Dangerous
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
Merit Medical Systems
Class I - Dangerous
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Class I - Dangerous
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Class I - Dangerous
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Class I - Dangerous
Incorrect blister labelling.
Class I - Dangerous
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50629M; 4) SHUNT PACK, Model Number: DYNJ40040C; 5) STIM IMPLANT PACK, Model Number: DYNJ53032C
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class I - Dangerous
The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.