FDA (Devices) recall action 94349
The FDA (Devices) publishes a recall like this one as 15 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 15 pages.
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
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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.
The DURAMAX STACKED TIP vascular catheter may contain loosely affixed metal shavings that could embolize and require surgical removal. Lot 5807208 affected, 15 units.
Angiodynamics' DURAMAX STACKED TIP vascular access device may contain loosely affixed metal shavings that could cause blood vessel blockage, potentially requiring surgical removal.
Angiodynamics recalls the Duramax Stacked Tip vascular access kit used for hemodialysis due to potential loose metal shavings that could enter the bloodstream and require surgical removal.
Angiodynamics recalls 455 DURAFLOW 2 hemodialysis kits for loose metal shavings that could embolize, potentially requiring surgical removal.
DURAFLOW 2 vascular access kits for hemodialysis are being recalled because some units may contain loosely affixed metal shavings that could travel through blood vessels and potentially require surgical removal.
Angiodynamics Inc. is recalling DURAFLOW 2 vascular catheter kits used for hemodialysis and apheresis access due to potential metal shavings that may detach and travel through the vascular system, potentially requiring surgical removal.
Angiodynamics is recalling 65 DURAFLOW 2 vascular access devices distributed in Virginia due to potential loose metal shavings that could enter the bloodstream and require surgical removal.
Angiodynamics recalled a vascular access catheter used for hemodialysis because it may contain loosely affixed metal shavings. These shavings could potentially detach and move through blood vessels, possibly requiring surgical removal.
Angiodynamics has voluntarily recalled 285 units of DURAMAX STACKED TIP vascular access catheters (lots 5807195 and 5807196) used for hemodialysis. The specific reason for the recall is not disclosed in the FDA notice.
DURAMAX hemodialysis vascular access kits are recalled due to potential metal shavings that could enter the bloodstream and require surgical removal. Thirty units distributed in Virginia are affected.
Angiodynamics is recalling DURAMAX STACKED TIP medical devices that may contain loosely affixed metal shavings with potential to embolize, requiring possible surgical removal. The recall affects 50 units distributed in Virginia.
Angiodynamics is recalling DURAFLOW 2 vascular access devices due to loose metal shavings that may travel through blood vessels, potentially requiring surgical removal.
Angiodynamics recalls DURAMAX STACKED TIP vascular access devices that may contain loosely affixed metal shavings. Metal shavings could embolize and potentially require surgical removal.
Angiodynamics DURAFLOW 2 hemodialysis kits may contain loosely affixed metal shavings that could enter the bloodstream. Metal fragments may require surgical removal if they embolize.
Angiodynamics is recalling the BioFlo DuraMax 15.5F Single Valve Sheath VascPak Kit due to possible loose metal shavings. Metal shavings could enter the bloodstream and require surgical removal.