Z-2254-2020 Class II Ongoing
FDA device recall Z-2254-2020 was initiated by Covidien Llc on May 12, 2020 and is designated Class II. Reason for recall: The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed. The recall status is ongoing. Affected quantity: 12,610 total.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- May 12, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,610 total
Product Description
Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).
Reason for Recall
The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.
Distribution Pattern
Worldwide distribution.
Code Information
Lots P9J1171Y P9K1395Y P9K1582Y