—#173243

Product

EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K111825, K160176
Affected lot / code info: N6B0080KX N6C0975KX

Why it was recalled

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

Root cause (FDA determination)

Process control

Action the firm took

All consignees were notified by letter delivered via Federal Express and/or certified mail beginning May 17, 2019. The letter informs customers of the recall of specific item codes and production lots of Covidien Endo GIA Articulating Reloads with Tri-Staple Technology due to the potential for a device to be missing one of two pin components that maintain alignment of the device jaws. Through this notification customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item codes and lots. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Endo GIA" Articulating Reloads with Tri-Staple Technology. " Complete the Recalled Product Return Form. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: Nationwide domestic distribution, worldwide foreign distribution.

Timeline

Recall initiated: 2019-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173243. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.