RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers/UDI: 27877022 8714729750031 28098229 8714729750031 28329450 8714729750031 27803952 8714729750079 27877021 8714729750079 27914711 8714729750079 27950226 8714729750079 28110693 8714729750079 27950225 8714729750116 28018192 8714729750116 28253295 8714729750116 28069582 8714729750154 27751896 8714729750178 27983611 8714729750178 28296770 8714729750192 27658435 8714729750239 27891175 8714729750239 28018195 8714729750239 27914712 8714729750277
- 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:
RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
Product Codes/Lot Numbers:
Lot Numbers/UDI: 27877022 8714729750031 28098229 8714729750031 28329450 8714729750031 27803952 8714729750079 27877021 8714729750079 27914711 8714729750079 27950226 8714729750079 28110693 8714729750079 27950225 8714729750116 28018192 8714729750116 28253295 8714729750116 28069582 8714729750154 27751896 8714729750178 27983611 8714729750178 28296770 8714729750192 27658435 8714729750239 27891175 8714729750239 28018195 8714729750239 27914712 8714729750277
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0781-2022
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