Z-1228-2023 Class II Ongoing
FDA device recall Z-1228-2023 was initiated by Covidien, LP on January 25, 2023 and is designated Class II. Reason for recall: Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue han… The recall status is ongoing. Affected quantity: 264 US; 5056 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2023
- Initiation Date
- January 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 264 US; 5056 OUS
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington and the countries of Australia, Austria, Belgium, Canada, Canary Islands, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Caledonia, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.