—#181548

Product

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).

FDA product code: GCI — Laryngoscope, Endoscope
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K912097
Affected lot / code info: Lots P9J1171Y P9K1395Y P9K1582Y

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Covidien Llc
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2020-05-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181548. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.