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Terminated

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

FDA Recall Z-2622-2017 · Posted None

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeGCJ
Date Initiated2017-05-09
Date Terminated2019-02-13
Product Quantity194,851

Reason for Recall

Cotton tip of the device may disengage due to insufficient adhesive

Firm Action

Medtronic consignees were notified via Federal Express or certified mail on May 9, 2017, and the letter informs customers of the potential for the tip of the device to disengage from the device and the actions they should take. Accounts requested to discontinue use, quarantine and return product. Customers are requested to complete and acknowledge receipt of the Urgent Field Corrective Action Notice. Questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2. For questions regarding this recall call 203-492-5000.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K931962NON-ABSORBABLE GAUZEUnited States Surgical, A Division of Tyco Healthc · 1993-12-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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