Recall Z-2622-2017— Covidien LLC

Name: FDA recall Z-2622-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-09

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2017-05-09, terminated 2019-02-13. It names one FDA 510(k) clearance: K931962. Product: Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding. Reason: Cotton tip of the device may disengage due to insufficient adhesive.

Recalling firm: Covidien LLC
Classification: Class II
Status: Terminated
Initiated: 2017-05-09
Terminated: 2019-02-13
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K931962 — NON-ABSORBABLE GAUZEUnited States Surgical, A Division of Tyco Healthc·cleared 1993-12-10

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

Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding

Reason for recall

Cotton tip of the device may disengage due to insufficient adhesive

Data sourced from openFDA. This site is unofficial and independent of the FDA.