Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- Reason for Recall:
- Sterility of device is compromised due to a sterile barrier breach
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0751-2022
Related Recalls
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Boston Scientific
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia