Recall Z-2254-2020 ยท GCI Laryngoscope, Endoscope
Covidien Llc
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).
| Date | May 12, 2020 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 an |
| Quantity | 12,610 total |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912097 | AUTO SUTURE ENDOSCOPIC FASCIA STAPLER United States Surgical, A Division of Tyco Healthc, Sep 19, 1991 |