medical Class II Updated 2022-03-23

Boston Scientific Corporation recalls Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/26

Recalled Product

Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040


Hazard / Issue

Sterility of device is compromised due to a sterile barrier breach

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Batch Numbers: 27446479 27448337 27470857 27473288 27479007 27488955 27519099 27583248 27584920 27609359 27610230 27616517 27674795 27679150 27681372 27682823 27710650 27715915 27740170 27742966 27746783 27747640 27770749 27779090 27781488 27784284 27806906 27808089 27813903 27818805 27869283 27872956 27955178 27958586 27965294 28021413 28054973 28118052 28296777 28296779 GTIN: 8714729778264
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