—#173248

Product

SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K111825, K160176
Affected lot / code info: N6E0033UX N6H0768UX N6H0772UX N6K0521UX N6K0522UX N6K0667UX N6K0668UX N6L0687UX N6M0399UX N7A0018UX N7A0213UX N7A0401UX N7A0837UX N7B0787UX N7C0238X N7C0470X N7E0496X N7E1088X N7F0670X N7H0962X N7J0370X N8A0188X N8B0057X N8B0483X N8B0940X N8D0365X N8D0649X N8E0092X N8E0213X N8E0516X N8E1178X N8F0483X N8F0819X N8F0974X N8J0440X N8L0589Y N8M0529Y N9A0050Y N9A0427Y

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 #173248. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.