FDA Device recall Z-0751-2022
Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
- FDA Device
- Class II
- ongoing
- Published 2022-03-23
On 2022-03-23 the FDA classified a Class II recall of Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040 by Boston Scientific, citing sterility of device is compromised due to a sterile barrier breach.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0751-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-12-22 |
| Published | 2022-03-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
Reason
Sterility of device is compromised due to a sterile barrier breach
Identifiers
| code_info | Batch Numbers: 27446479 27448337 27470857 27473288 27479007 27488955 27519099 27583248 27584920 27609359 27610230 27616…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0751-2022%22
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