Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
Galt Medical Corporation
The hazard
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
UPC 00841268107250Would you have heard about this one?
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