Recall Z-1834-2019— Covidien LLC
Class II · Ongoing
Class II FDA medical device recall by Covidien LLC, initiated 2019-05-17. It names 2 FDA 510(k) clearances: K160176, K111825. Product: SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT. Reason: 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..
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-05-17
- Firm location
- North Haven, CT, United States
510(k) clearances named in this recall
2 on FDA's record- K160176 — Signia Stapler
- K111825 — ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.