Z-1080-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- March 3, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,946 units. US: 6,916; OUS: 30
Product Description
EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
Reason for Recall
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, IRELAND, Israel, Italy, Kuwait, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Unit. Arab Emir.
Code Information
All lots GTIN: 08714729993605