Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - 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).
- Company
- Covidien Llc
- Recall Initiated
- May 12, 2020
- Recall Number
- Z-2252-2020
- Quantity
- 12,610 total
- Firm Location
- Mansfield, MA
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
Worldwide distribution.
Lot / Code Info
Lots P9J0241Y P9J0242Y P9J0243Y P9K1140Y P9K1663Y P9K1141Y
Root Cause
Process control
Action Taken
All consignees were notified by letter titled "Urgent Medical Device Recall" delivered via Federal Express and/or certified mail beginning May 12, 2020. The letter informs customers of the recall of specific item codes and production lots of Multifire hernia staplers due to a manufacturing assembly error. Use of a device with this condition may result in the failure of staples to properly advance within the staple cartridge when the instrument handle is compressed. Customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item code and lot. " Return affected product. " Promptly forward the information from the customer communication to any recipients to whom they have distributed any of the affected product. " Complete the Recalled Product Return Form even if you do not have inventory. If you have any questions about this event, you may contact Medtronic via email at rs.assurancequality@medtronic.com